Visualization of the Papilla Through Use of the NuView Device in Patients With FAP
Conditions: Familial Adenomatous Polyposis
Sponsor: Vanderbilt University Medical Center

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TI T L E:  Vis u aliz ati o n of t he p a pill a t hr o u g h use of t he N u Vie w de vice i n  p atie nts 
wit h  F A P  
Pr ot oc ol Versi o n  D ate:  M a y  5, 2 0 2 2 

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1.
P U R P O S E
T he N u Vie w d e vice is a si n gle-use distal e n d osc o pe attac h me nt t hat is i nte n de d t o facilitate direct 
vis ualizati o n of t he pa pilla wit h a f or war d vie wi n g e n d osc o pe i n or der t o eli mi nate t he nee d f or 
passa ge of t he m uc h b ul kier, n o n -i nt uiti ve, ris k pr o ne si de- vie wi n g  e n d osc o pe t o vis ualize t he 
pa pilla.  I n t his earl y feasi bilit y st u d y, t he N u Vie w de vice will be use d t o atra u maticall y i nsert an d 
na vi gate a  c o n ve nti o nal f or war d -vie wi n g u p p er e n d osc o pe ( gastr osc o p e) fr o m i nserti o n at t he 
m o ut h, t hr o u g h t he es o p h a g us, t he st o mac h, a n d i nt o d u o de n u m t o vis ualize t he pa pilla i n  p atie nts 
wit h   fa milial a de n o mat o us p ol y p osis  ( F A P). F A P is a here ditar y c o n diti o n i n w hic h a pers o n 
de vel o ps n u mer o us preca ncer o us p ol y ps, calle d a de n o mas, wit hi n t he s m all a n d lar g e i ntesti ne. 
T hese p atie nts als o h a ve a hi g h pre val e nce of a d e n o mas  t hat d e vel o p o n t he d u o de nal pa pilla , 
w hic h are partic ularl y har d t o vis ualize d ue t o t he c ur vat ure a n d ge o metr y of t he s mall i ntesti ne 1. 
C urre ntl y, it is rec o m me n de d t hat F A P patie nts u n der g o  serial e n d osc o pi c e xa ms t o assess t he 
c ol o n f or p ol y p f or mati o n e ver y year  a n d e v er y 2-3 years t o l o o k f or a de n o mas i n t he s mall 
i ntesti ne— s pecificall y o n t he d u o de nal pa pilla. T his re q uires t w o differe nt s pecialize d e n d os c o pes 
t o perf or m t he u p p er e n d osc o pic pr o ce d ure. T h e first e n d os c o pe t h at  t he  e n d osc o pist uses is a 
f or war d faci n g gastr os c o pe, wit h w hic h t hey are a ble t o vis ualize t he  st o mac h a n d p orti o ns of t he 
d u o de n u m. D ue t o t h e a nat o mic l ocati o n of t h e pa pilla, t he f or war d -vie wi n g e n d osc o pe is n ot 
a de q uate f or vis ualizati o n  of t he pa pilla,  a n d t heref ore t he e n d osc o pist m ust s witc h t o a sec o n d 
s pecialize d e n d os c o pe (calle d a d u o de n osc o pe ) t hat all o ws f or si de vie wi n g b ut lac ks f or war d 
vis ualizati o n. T here  are  se veral  w ell - k n o w n pr o ble ms  wit h  d u o de n osc o pes .  First,  t he y are 
n ot ori o usl y diffic ult t o sterilize a n d ha ve bee n li n ke d t o alar mi n gl y hi g h i nfecti o ns rates t hat ha ve 
i n s o me cas es r es ulte d i n patie nt deat hs2, 3. T he F D A has e ve n iss ue d a call-t o-acti o n t o me dical 
de vice ma n ufact urers t o i n ve nt ne w dis p osa ble s ol uti o ns  t o miti gate or eli mi nate t his pr o ble m4, 5. 
Sec o n dl y, si de- vie wi n g e n d osc o pe t h at are c urre ntl y use d are diffic ult t o na vi gate b eca us e t he y 
lac k f or war d vie wi n g ca pa bilities. T he N u Vi e w de vice was d esi g ne d t o eli mi nate t he nee d f or a 
d u o de n osc o pe  b y  e na bli n g  a  f or war d  faci n g  gastr osc o pe  t o  als o  ha ve  s o me  si de - vie wi n g 
ca pa bilities. I n t his earl y feasi bilit y st u d y, t he N u Vie w de vice will be use d wit h a f or w ar d faci n g 
gastr osc o pe t o e n a ble F A P patie nts t o u n der g o t heir  r o uti ne  s cree ni n g e n d osc o pic e x a m. W e 
h y p ot hesize t hat t he mi ni mall y i n vasi ve e n d osc o pic pr oce d ure ma y offer t he f oll o wi n g be n efits: 
( 1) r e d uce d i nfecti o n rates d ue t o t h e eli mi nati o n of t he nee d f or a s p ecialize d si de-vie wi n g
d u o de n osc o pe, ( 2)  s h ort er pr oce d ur e ti me i ncl u di n g s h orter ge neral a nest hesia ti me b y eli mi nati n g
t he nee d t o s witc h e n d os c o pes d uri n g t he pr oce d ure, a n d ( 3 ) yi el d p ote ntiall y less tra u ma t o patie nt
tiss ue d ue t o t he atra u m atic feat ur es of t he N u Vie w  (o nl y nee di n g t o i nsert a n d re m o v e o ne
e n d osc o pe as c o m par e d t o usi n g t wo differe nt e n d osc o pes t o c o m plete t he e xa mi nati o n).
We pr o p os e a n earl y f easi bilit y st u d y t o deter mi ne if vis ualizati o n of t he p a pilla is p ossi ble usi n g 
a f or w ar d faci n g g astr os c o pe e q ui p p e d wit h t he N u Vie w . T he st u d y  will i n v ol ve o nl y  ot her wise 
healt h y  F A P patie nts bet wee n t he a ge of 1 8 a n d 7 0  (see selecti o n criteri a f or a f ull descri pti o n).  
1J. R. Ale xa n der, R. W. B urt , “Hi g h pre vale nce of a de n o mat o us p ol y ps of t he d u o de nal pa pilla i n fa milial a de n o mat o us 
p ol y p osis ” Di g Dis Sci. 1 9 8 9; 3 4( 2): 1 6 7 -1 7 0.  
2R. M. H u m p hries a n d G. Mc D o n nell, “ S u per b u gs o n d u o de n osc o pes: T he c halle n ge of clea ni n g a n d  disi nfecti o n  of 
re usa ble de vices,” J o ur nal of Cli nical Micr o bi ol o g y, v ol. 5 3, n o. 1 0, p p. 3 1 1 8, 2 0 1 5. 
3U nite d States Se nate Heal t h, E d ucati o n, La b or a n d Pe nsi o ns C o m mittee, “ Pre ve nta ble Tra ge dies: S u per b u gs a n d 
H o w I neffecti ve M o nit ori n g of Me dical De vice Safet y Fails Patie nts,” 2 0 1 6.  
4F D A,  “ F D A  rec o m me n ds  healt h  care  facilities  a n d  ma n ufact urers  be gi n  tra nsiti o ni n g  t o  d u o de n osc o pe s  wit h 
dis p osa ble c o m p o ne nts t o re d uce ris k of patie nt i nfecti o n,” 2 0 1 9.  
5F D A, “ T he F D A C o nti n ues t o Re mi n d Facilities of t he I m p orta nce of F oll o wi n g D u o de n osc o pe  Re pr ocessi n g  

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I nstr ucti o ns: F D A Safet y C o m m u nicati o n,” 2 0 1 9. 
T he cli nical practice at V a n der bi lt U ni versit y Me dical Ce nter is t o first p erf or m t h e r o uti ne u p per 
e n d osc o pic  e x a m  wit h  a  f or war d - vie wi n g gastr osc o pe t o  e val uate  t he  patie nt’s   es o p ha g us, 
st o mac h, a n d d u o de n u m. After t his has b ee n c o m plete d, t he f or w ar d-vie wi n g e n d osc o pe will be 
re m o ve d fr o m t he patie nt a n d o utfitte d wit h t he E n d o T heia N u Vie w.  T he e n d osc o pe wit h N u Vie w 
will t he n  be i nserte d tra ns orall y d o w n t he es o p ha g us, tra verse t he st o mac h, a n d be passe d i nt o t he 
d u o de n u m f or vis ualizati o n of t he pa pilla. After t he pa pilla is vis ualize d, t he e n d osc o p e wit h 
N u Vie w will be re m o ve d fr o m t he patie nt.  As per sta n dar d of care, t he c o n v e nti o nal si de - vie wi n g 
e n d osc o pe will t he n be i nserte d tra ns orall y d o w n t he es o p ha g us, tra verse t he st o mac h, a n d be 
passe d  i nt o t he d u o d e n u m f or vis ualizati o n of t he pa pilla.  T he si de -vie wi n g e n d osc o pe will t he n 
be re m o ve d fr o m t he pati e nt. 
We  pla n  t o e nr oll 3 F A P patie nts w h o are alrea d y sc he d ule d t o u n der g o t heir sta n dar d of care 
e n d osc o pic e xa m. T he pri mar y  e n d p oi nt of t he st u d y is s uccessf ul vis ualizati o n of t he pa pilla wit h 
t he N u Vie w platf or m. 
2.
D E S C RI P TI O N  O F  D E VI C E
T he E n d o T heia N u Vie w is a distal e n d osc o pe attac h me nt t y pe de vice w hic h is i nte n de d “ t o be att ac he d t o 
t he dist al e n d of t he e n d osc o pe t o f acilit ate e n d osc o pic t her a py, t o be use d f or t he f oll o wi n g: 
•
Kee pi n g t he s uit a ble de pt h of e n d osc o pe’s vie w fiel d
•
Hel pi n g t he e n d osc o pe wit h bei n g i nserte d i nt o t he g astr oi ntesti n al tr act ”
T he E n d o T heia N u Vie w  ca n be see n i n Fi g ure 1 . 
Fi g ur e 1 . T h e N u Vi e w d e vi c e is a dist al e n d os c o p e att a c h m e nt d e vi c e w hi c h f e at ur es (1) a n atr a u m ati c ti p t o h el p wit h 
i ns erti o n i nt o t h e b o d y, (2) a si d e -vi e wi n g s urf a c e w hi c h e n a bl e s t h e p h ysi ci a n wit h m or e l at er al vi e wi n g c a p a biliti e s, 
a n d (3) a n e v erti n g w e b w hi c h i nt er a cts wit h p ati e nt tis s u e t o h el p m ai nt ai n t h e c orr e ct fi el d of vi e w  a n d i n cr e as e 
vis u aliz ati o n.  

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Distal e n d osc o pe attac h me nt de vices are n ot ne w. T here are ma n y s uc h de vices c urre ntl y o n t he 
mar ket a n d i n use wit hi n t he cli nical setti n g. S o me si milar distal e n d osc o pe attac h me nt de vices o n 
t he mar ket ar e t he Arc E n d oc uff (K 1 5 1 8 0 1 ) a n d t he Re veal Distal Attac h me nt Ca p (K 1 4 0 3 1 5 ). 
T hese de vices f u n cti o n si milarl y t o t he N u Vie w de vice b y attac hi n g t o t he e n d osc o pe , mai ntai ni n g 
t he c orrect fiel d of vie w, a n d hel pi n g wit h atra u matic i nserti o n of t he e n d osc o pe.   T he N u Vie w 
de vice mai ntai ns attac h me nt wit h t he e n d os c o p e t hr o u g h a press -fitti n g attac h me nt t hat is ti g ht 
e n o u g h t o mai ntai n attac h me nt b ut n ot ti g ht e n o u g h t o da ma g e t he e n d osc o pe i n a n y wa y, si milar 
t o  ot her  F D A  a p pr o v e d  distal  attac h me nts.  Si milarl y,  t he  N u Vi e w  d e vice  h as  a n  atra u matic  
i nserti o n ti p t hat is r o u n de d a n d ma d e fr o m a bi oc o m pati ble material , w hic h is mea nt t o facilitate 
atra u matic i nteracti o n wit h t he patie nt’s tiss ue a n d e na ble safe i ns erti o n of t he e n d os c o pe i nt o t he 
patie nt . A n ot her as p ect of t he N u Vie w  de vice is t hat it c o ntai ns s oft, fle xi ble si de pr ojecti o ns t o 
s m o ot h o ut t he m uc osal f ol ds i nsi de t he gastr oi ntesti nal ( GI) tract (si milar t o ot her F D A a p pr o ve d 
distal e n d osc o pe attac h m e nt de vices  s u c h as t he E n d o C uff Visi o n ®  (Ol y m p us A merica, P A, U S A ) 
a nd t he E n d o Ri n gs ™ ( E N D O -AI D i nc., P A, U S A) , as well as a si de-vie wi n g reflecti ve s urface 
t hat will  re direct  a  p orti o n  of  t he  fiel d  of  vie w  of  t he  e n d osc o pe.  T he  s oft  pr ojecti o ns  are  
pr o xi mall y -biase d, all o wi n g t he m t o f ol d d o w n o nt o t he e n d osc o pe b o d y d uri n g i nserti o n, a n d 
e vert u p o n retr acti o n t o e x pa n d a n d flatte n m uc os al f ol ds, t here b y pr o vi di n g a n e n h a nce d vie w of 
t he l u me n as vie we d t hr o u g h t he si de-vie wi n g reflecti ve s urface. T hese feat ures are mea nt t o hel p 
kee p a s uita ble de pt h of t he e n d osc o pe’s vie w fiel d a n d t o gi ve t he s ur ge o n a n e xcelle nt vie w of 
t he m uc osal li ni n g t o vis ualize tiss ue t o t he si de of t he e n d osc o pe, i n a d diti o n t o preser vi n g a 
p orti o n of t he n or mal f or war d-faci n g fiel d of vie w ca pa bilities. T he s ha pe of t he N u Vie w d e vice, 
t he fle xible si de pr ojecti o ns, a n d t he si de vie wi n g reflecti ve s urface will ai d i n kee pi n g t he s uita ble 
de pt h of e n d os c o pe’s fiel d of vie w a n d i ncrease t he s ur ge o n’s a bilit y t o vis ualize desire d tiss ue 
tar gets b y s m o ot hi n g m uc osal f ol ds a n d pre ve nti n g tiss ue fr o m c olla psi n g ar o u n d t he e n d os c o pe. 
T he de v ices use d i n t his st u d y are t he f oll o wi n g: 
I.
Ol y m p us Gastr osc o pe GI F -H 1 9 0 w hic h is F D A cleare d f or e n d os c o p y a n d e n d osc o pic
s ur ger y wit hi n t he u p per di gesti ve tract.
II.
N u Vie w c o nsisti n g of a s oft distal e n d osc o pe attac h me nt de vice (i n vesti gati o nal de vice ).
III.
Ol y m p us D u o de n osc o pe TJ F -Q 1 8 0 V w hi c h is F D A cleare d f or e n d osc o p y a n d e n d osc o pic
s ur ger y wit hi n t he d u o de n u m.
T a bl e 1 . D e vi c e s us e d i n t his st u d y 
Pr o d uct  
M o del  
F D A I nf or mati o n  
A vaila bilit y  
Ol y m p us 
Gastr oi ntesti nal 
Vi de osc o pe  
GI F -H 1 9 0  
K 1 1 2 6 8 0  
F D A cleare d a n d 
c om merciall y a vaila ble  
N u Vie w De vice  
N ot a vaila ble 
I n vesti gati o nal 
N ot c o m merciall y 
a vaila ble 
Ol y m p us
 Vi de o
 
D u o de n osc o pe  
TJ F - Q 1 8 0 V 
K 1 4 3 1 5 3  
F D A cleare d a n d 
c o m merciall y a vaila ble 
3.
P R O T O C O L
3. 1. 1  S y n o psis  

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I n vesti g ati o n al De vice:  N u Vie w  
St u d y  Title:  Vis ualizati o n of t he pa pilla t hr o u g h use of t he N u Vie w de vi ce i n F A P patie nts.  
St u d y Desi g n:  Earl y Feasi bilit y St u d y  
N u m ber  of P artici p a nts:  3  
St u d y  P o p ul ati o n: A d ult F A P patie nts  w h o are alrea d y sc he d ule d f or t heir sta n dar d of care 
u p per e n d osc o pic F A P scree ni n g e x a mi nati o n.  
St u d y  D ur ati o n: U p per e n d osc o pic e xa mi nati o ns f or F A P are relati vel y s h ort  d urati o n o ut-
patie nt pr oce d ures  l asti n g 2 0- 30 mi n utes i n d urati o n. As is sta n dar d of care at V U M C, a p ost-
pr oce d ur e f oll o w- u p p h o ne call  is t he n c o n d uct e d 3- 5 da ys p ost- pr oce d ure.  
Sc he d ule: ( 1)  Scree ni n g of  patie nts  f or  meeti n g  i ncl usi o n  criteria;  ( 2) R o uti ne  u p per 
e n d osc o pic  e x a mi nati o n  wit h  f or wa r d-vie wi n g  e n d osc o pe;   (3) Passa g e  of  t he  f or war d -
vie wi n g e n d osc o p e wit h N u Vie w; ( 4) Passa g e of t he c o n v e nti o nal si de -vie wi n g e n d osc o p e; 
( 5) F oll o w- u p p h o n e call 3 -5 da ys p ost e xa mi nati o n as per V U M C   sta n dar d practice  f or
patie nts w h o ha ve u n der g o ne e n d osc o p y.
3. 1. 2  St u d y  O b jecti ve 
T he  o bjecti ve  of t his e a rl y fe asi bilit y st u d y is t o deter mi ne  if vis ualizati o n of t he pa pilla is 
p ossi ble usi n g a f or war d-faci n g e n d os c o pe o utfitte d wit h t he  N u Vie w de vice.  
3. 1. 3  St u d y  Desi g n  
3. 1. 3. 1  O ver vie w  
T his earl y feasi bilit y st u d y will be a pr os pecti ve cli nical trial i n w hic h 3 patie nts will be  e nr olle d. 
All  patie nts  will  u n der g o t heir r o uti ne yearl y u p per e n d osc o pic e xa mi nati o n usi n g t he c o n ve nti o nal 
f or war d-vie wi n g gastr osc o pe, si de -vie wi n g gastr osc o pe, a n d f or war d -vie wi n g  gastr osc o pe  e q ui p pe d 
wit h t he  N u Vie w  platf or m .  
3. 1. 3. 2  St u d y  E n d p oi nts  
P RI M A R Y  
T he  pri mar y   st u d y  e n d p oi nt will   be s uccessf ul vis ualizati o n  of  t he  pa pilla  wit h  a  sta n dar d 
gastr osc o pe e q ui p pe d wit h t he N u Vie w platf or m .  
S E C O N D A R Y  
i.
Ti me  of pr oce d ure as r ec or de d b y researc h p ers o n nel
ii.
Ease of use of t he de vice as rec or de d b y t he e n d osc o pist  via t h e c o m pleti o n  of a N A S A tas k
l oa d i n de x q uesti o n naire p ost- pr oce d ure

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3. 1. 4  St u d y  De vices  
T he N u Vie w is a n i n vesti gati o nal distal e n d osc o pe  attac h m e nt t y pe d e vice t hat c o nsists of s oft, 
fle xi ble, a n d bi oc o m p ati ble 3 D pri nte d material, a n e m be d d e d o ptical  mirr or , a n d bi o c o m pati ble 
a d hesi ve. All materials use d i n t he N u Vie w ha v e b ot h bee n c o nfir me d  t o be bi oc o m pati ble a n d 
ha ve bee n s h o w n t o  wit hsta n d a ut ocla ve sterilizati o n well . F or all bi oc o m pati bilit y a n d sterilit y 
verificati o n testi n g i nf or mati o n please refer t o A p pe n di x B .   
3. 1. 5  P artici p a nt Selecti o n  
3. 1. 5. 1  I ncl usi o n Criteri a  
1.
Male  or fe mal e, 1 8 t o 7 0 years  of a ge.
2.
A ble  t o pr o vi de writte n  i nf or me d c o nse nt.
3.
Ha ve F A P
3. 1. 5. 2  E xcl usi o n Criteri a  
1.
Fe males  w h o  are   pr e g na nt. As  p art   of  r o uti ne pre - o perati ve care, all fe males  of
c hil d beari n g p ote ntial will u n der g o eit her uri ne or bl o o d pre g na nc y testi n g.
2.
Ca ncer p ositi ve s u bjects or a n y patie nts c urre ntl y u n der g oi n g a n y treat me nt or t hera p y t o
treat, c ur e, or miti gate ca ncer.
3.
Patie nts w h o d o n ot meet i ncl usi o n criteria
4.
Patie nts w h o are u na bl e or u n willi n g t o pr o vi de i nf or me d c o ns e nt
3. 1. 6  St u d y  Pr oce d ures  
3. 1. 6. 1  Scree ni n g  
P ote ntial s u bjects will be i de ntifie d fr o m t he list of patie nts i n t he Va n der bilt U ni versit y  Me dical  
Ce nter  Di gesti ve Disease Ce nter  w h o are sc h e d ule d t o u n der g o t heir e n d osc o pic scree ni n g f or F A P  
b y me m bers of t he V U M C cli nical researc h trai ne d pers o n nel tea m. T h os e p artici pa nts w h o e x press 
i nterest i n ta ki n g p art i n t he res ear c h st u d y will be as k e d t o si g n a writte n i nf or me d c o ns e nt t hat 
has bee n a p pr o ve d b y t he Va n der bilt U ni versit y  Me dical Ce nter  I R B. Partici pa nts  will  ha ve t he 
st u d y e x plai ne d  t o t he m a n d will  be gi ve n t he o p p ort u nit y t o read a n d re vie w t he c o nse nt d oc u me nt 
a n d  ha v e  a n y  q uesti o ns  a d dress e d.  O n ce  i nf or me d   c o nse nt is  o btai ne d, fi nal eli gi bilit y f or 
e nr oll me nt i nt o t he st u d y will  be deter mi ne d  b ase d  o n  t he  i ncl usi o n/e xcl usi o n criteria. 
Partici pa nts will u n der g o pre -o p erati ve  a n d p ost - o perati ve pr o ce d ures as p er r o uti ne sta n d ar d of 
care f or t heir V U M C e n d osc o pic e xa m. We a ntici pate e nr olli n g 3 patie nts t o c o m plete t he st u d y.  
3. 1. 6. 2  D a y  of E n d osc o p y  
O nce t he patie nt  has  bee n  s uccessf ull y  pre pare d  f or t he e n d osc o pic  pr oce d ure a n d has bee n  
a d mi nistere d  m o nit ore d a nest hesia care ( M A C) b y t he V U M C A nest hesia tea m  as per r o uti ne  care,  
t he f oll o wi n g ste ps will  be  f oll o we d. 
 N ote: o nly ste p “ b) ” bel o w devi at es fr o m t he c urre nt st a n d ar d cli nic al pr actice f or  u p per 
e n d osc o pic e x a mi n ati o n of F A P p atie nts. Ste p “ b) ” is w he n t he i nvesti g ati o n al N o n- Si g nific a nt 
Ris k ( N S R) device is use d a n d t he o nly ste p  t h at is n ot us u ally perf or me d d uri n g F A P e n d osc o pic 

1 9  
e x a mi n ati o ns. 
a) E n d osc o pic assess me nt usi n g a st a n d ar d g astr osc o pe. T his assess me nt is t he first ste p i n t he
r o uti ne  F A P  patie nt  e n d osc o pic  e xa mi nati o n.  D uri n g  t his  ste p,  t he  e n d osc o pist i ntr o d uces  a
gastr osc o pe i nt o t he patie nt t o assess t he es o p ha g us, st o mac h, a n d d u o d e n u m f or p ol y ps. T his will
be perf or me d per sta n dar d of car e wit h o ut de viati o n fr o m sta n dar d of care pr oce d ure.
b) E n d osc o p ic vis u aliz ati o n of t he p a pill a usi n g a g astr osc o pe e q ui p pe d wit h t he N u Vie w . After
t he gastr osc o p e ass ess me nt is c o m plete a n d t he gastr osc o pe is re m o v e d fr o m t he patie nt,  t he
N u Vie w de vice will be attac he d t o t he gastr osc o pe, i ntr o d uce d i nt o t he patie nt, a n d t he pa pilla will
be vis ualize d. Ste ps i n se q ue ntial or der are:
1. T he N u Vie w d e vice’s sterile pac ka gi n g will be i ns p ecte d a n d c o nfir me d i nt act
2. T he N u Vie w  p ac k a ge will be o pe ne d
3.
T he N u Vie w will t he n be presse d o nt o t he distal e n d of t he gastr osc o pe usi n g t he press -fitti n g
attac h me nt feat ure  a n d c o nfir me d t o be sec urel y faste ne d
4.
T he gastr osc o p e e q ui p pe d wit h t he N u Vie w will be i nserte d i nt o t he patie nt
5.
T he gastr osc o pe will be na vi gate d t o t he d u o de n u m a n d t he pa pilla will be vis ualize d usi n g
t he N u Vie w
6.
T he gastr osc o p e e q ui p pe d wit h a N u Vie w will be re m o ve d fr o m t he p atie nt .
c) D u o de n osc o pe vis u aliz ati o n of t he p a pill a as a sec o n d ary c o nfir m ati o n usi n g a n ot her cli nic ally
acce pte d met h o d.  F oll o wi n g pa pilla vis ualizati o n usi n g t he N u Vie w , t h e pa pilla will be vis ualize d
a n d i ns pecte d a gai n usi n g a d u o de n osc o p e. T his will be perf or m e d i n t he sta n dar d met h o d, usi n g
t he  sta n dar d  pr ot oc ol  f or  F A P  p atie nts  d uri n g  t heir  r o uti ne s cree ni n g  u p per  e n d osc o pic
e xa mi nati o n. T he e n d os c o pist will i nsert a d u o d e n osc o pe  i nt o t he p atie nt a n d n a vi gate t o t he
d u o de n u m as is n or m al wit h r o uti ne e n d osc o pi c pr oce d ures f or p atie nts wit h F A P. Usi n g t his
acce pte d cli nical met h o d, t he y will i ns pect t he p a pilla t o c o nfir m w hat was vis ualize d usi n g t he
N u Vie w de vice. T his is a pr otecti o n i n li ne wit h w hat is o utli ne d i n 2 1 C F R 8 1 2 , w hic h states t hat
a n y dia g n ostic N S R de vice s h o ul d ha ve a c o nfir mati o n of dia g n osis usi n g a sec o n d cli nicall y
acce pte d met h o d. O nce t he pa pilla has bee n vis ualize d usi n g t he d u o de n osc o pe, t he d u o de n osc o pe
will be re m o ve d fr o m t he patie nt i n t he sta n dar d cli nical met h o d.
d) A ny  a dverse  eve nts  occ urri n g  d uri n g  t he  s ur gic al  pr oce d ure will  be   d oc u me nte d. A n y
a d verse e ve nts t hat occ ur  d uri n g t he pr oce d ure will be d oc u me nte d a n d re p orte d i n acc or d a nce
wit h 2 1 C F R 8 1 2 a n d Va n der bilt’s I R B pr ot oc ols.
3. 1. 6. 3  P ost -o per a ti v e visit/f oll o w u p 
I n li ne wit h sta n dar d cli nical practice f or patie nts w h o ha ve recei ve d M A C at V U M C, t he p atie nt 
is o bser ve d f or 3 0 mi ns d uri n g t he i m me diate p ost- o perati ve peri o d a n d t hen release d t o a c ha per o ne 
t o lea ve t he e n d osc op y u nit.  T he patie nt t he n recei ves a p ost-o perati ve p h o ne call 3 -5 da ys post pr oce d ure t o 
i n q uire a b o ut stat us of t he patie nt . 
Pri mar y E n d p oi nt: S uccessf ul  vis ualizati o n of t he pa pilla wit h a sta n dar d gastr osc o pe e q ui p pe d 
wit h N u Vie w.  
Sec o n dar y  E n d p oi nts: 

2 0  
i. 
Ti me of t he pr oce d ure will be rec or d e d.
ii.
E n d osc o pist s ur ve y re gar di n g ease of us e a n d ot her s pecifics a b o ut t he N u Vi e w ( N A S A Tas k
L oa d I n de x)
3. 1. 6. 4  P artici p a nt  Ter mi n ati o n/ Wit h dr a w al 
Patie nts  ma y  be ter mi nate d fr o m t he st u d y f or t he f oll o wi n g reas o ns: 
-
A c ha n ge i n patie nt’s healt h stat us t hat w o ul d precl u de c o nti n uati o n i n t he st u d y  (e. g. car diac
e ve nt d uri n g s ur gical pr oce d ure). If t his w o ul d o cc ur,  t he patie nt  will c o nti n ue t o be f oll o we d as
per  r o uti ne car e.
-
If t he patie nt  c ha n ges  t h eir mi n d  a n d re q uests t o be wit h dra w n  fr o m st u d y s h o ul d t his occ ur, d ata
will  c o nti n ue t o be c ollecte d u nless t he patie nt  re q uests i n writi n g f or data  c ollecti o n t o cease.
3. 1. 7  T a bl e of Pr oce d ures  
T a bl e 2 . St u d y Pr o c e d ur e s 
Scr e e ni n g  
E n d osc o pic 
E x a mi n ati o n 
F oll o w  u p 
O bt ai n  I nf or m e d C o ns e nt  
X  
R evi e w  I ncl usi o n/ Excl usi o n Crit eri a  
X  
R evi e w  M e dic al  Hist or y  
X  
R o uti n e Pr e g n a nc y T esti n g ( uri n e or  
bl o o d)  
X  a 
G astr osc o p e ass ess m e nt of tiss u e  
X  
E n d osc o pic  V ali d ati o n of t ar g et wit h 
t h e N u Vi e w 
X b  
E n d osc o pic  c o nfir m ati o n  of  t ar g et  
usi n g a st a n d ar d D u o d e n osc o p e  
X 
R evi e w A dv ers e  E v e nts  
X  
X  
E n d osc o pic P ost -O p  
N A S A/ Q u esti o n n air e  
X b  
( a) P erf or m e d  pr e -o p er ativ el y  f or w o m e n  of c hil d b e ari n g  p ot e nti al
( b) T h e I nv esti g ati o n al St e p i n t his st u dy pr oc e d ur e. All ot h er st e ps wit hi n t h e pr ot oc ol will b e p erf or m e d p er t h e st a n d ar d of c ar e
3. 2  D at a A n al ysis  
I n t his earl y feasi bilit y st u d y, o ur pri mar y e n d p oi nt is s uccessf ul vis ualizati o n of t he pa pilla wit h 
a sta n dar d g ast r osc o pe e q ui p pe d wit h t he N u Vie w. Pr oce d ure ti me will als o be ca pt ure d as a sec o n dary 
e n d p oi nt.  
We  will  st o p e nr olli n g patie nts  i n t his st u d y if: 
1.
We  d o n ot b elie ve  t hat a d diti o nal patie nts  s h o ul d u n der g o t h e pr o ce d ure b eca use  t he ris ks
of t he pr oce d ure o ut wei g h t he p ote ntial be nefits  t o partici pa nts
a n d/ or 

2 1  
2.
A n  u na ntici p ate d  a d vers e eff ect  w o ul d warra nt  t hat  t he st u d y be st o p pe d f or assess me nt
of t he eff ect.
3. 3  Q u alit y  Ass ur a nce  
T he c o n d u cti o n of t his earl y feasi bilit y st u d y will be o vers ee n b y t he PI. T h e PI will meet wit h t he  
s u b-i n vesti gat ors a n d r es earc h staff t o ass ure pr ot oc ol a d here nce a n d acc urac y of data c ollecti o n. 
Pri or t o st u d y i nitiati o n, all st u d y staff will be trai n e d re g ar di n g t he  a p pr o ve d pr ot oc ol. All  dat a  
will be  e nter e d i nt o a p ass w or d pr ot ecte d  c o m p uter data b ase b y q ualifi e d res earc h  staff. A n y  
i nc o nsiste ncies i n t he data  will  be rec o ncile d a n d d oc u me nte d a p pr o priat el y. As t here will  be o nl y 
3 s u bjects i n t his trial, all s u bject rec or ds will  be re vie we d b y t he PI . 
3. 4  Re g ul at or y C o nsi der ati o ns  
3. 4. 1  
A d verse  E ve nts/ Eff ects  
3. 4. 1. 1  
Defi niti o ns  
A dverse eve nt is defi ne d as a n y u n desira bl e e x perie nce ass o ciate d wit h t he use of t he de vi ce u n der 
st u d y t hat a p pears or w orse ns d uri n g t he cli nical st u d y fr o m t he peri o d  c o m me nci n g wit h t he 
s ur gical pr oce d ure t hr o u g h t he ti me t he partici pa nt c o m pletes t he st u d y, a n d t hat ma y or ma y n ot 
be relate d t o t he i n v esti gati o nal de vice or st u d y relate d pr oce d ures.  
A rel ate d a dverse eve nt is a n e ve nt i n w hic h t here is a reas o na ble p ossi bilit y t hat t he  i n vesti gati o nal 
de vice  or  st u d y r elate d pr oce d ures  ca use d or c o ntri b ute d t o t he e ve nt.  
A n u n a ntici p ate d a dverse device effect is defi ne d as a n y s eri o us a d vers e e v e nt o n healt h or safet y 
or a n y li fe-t hreate ni n g pr o ble m or deat h ca us e d b y, or ass ociate d wit h, a de vice, if t hat effect,  
pr o ble m, or d eat h  w as  n ot pre vi o usl y i de ntifie d i n nat ure,  s e verit y, or  de gree of  i nci de n ce i n t he 
i n vesti gati o nal pla n or a n y ot her u na ntici pate d s eri o us pr o ble m ass ociate d wit h a de vice t hat  relat es 
t o t he ri g hts, safet y, or welfar e  of s u bjects. 
A seri o us a dverse  eve nt is defi ne d  as a n a d v erse e ve nt w here b y  t he patie nt  o utc o me meets a n y  of  
t he f oll o wi n g criteria:  
a.
Res ults  i n deat h
b.
Is life-t hreate ni n g ( defi n e d as a n e v e nt i n w hic h t he partici pa nt was at s u bsta ntial ris k of
deat h  at t he ti me of t he a d verse  e ve nt, or us e or c o nti n ue d us   of  t he d e vice   mi g ht  ha ve
res ulte d i n t he deat h  of t he patie nt)
c. Re q uires  i n patie nt h os pitalizati o n
d. Pr ol o n gs a n e xisti n g h os pitalizati o n
e.
Res ults i n persiste nt or si g nifica nt disa bilit y (s u bsta ntial disr u pti o n of a  p e rs o n’s a bilit y t o
c o n d uct n or mal life f u ncti o ns)
f.
Res ults  i n a c o n ge nital a n o mal y or birt h  defect
g.
Re q uires  me di cal  or  s ur gical i nter v e nti o n t o  precl u de p er ma ne nt  i m pair me nt of a b o d y
f u ncti o n or pre v e nt per m a ne nt da ma g e t o a b o d y str uct ure.

2 2  
h.
T he e ve nt d oes n ot fit a b o ve criteria (a) t hr o u g h ( g), b ut ma y je o par dize t he  patie nt  a n d
ma y  re q uire me di cal  or  s ur gical i nter ve nti o n t o pre ve nt a n y of (a) t hr o u g h ( g) a b o ve.
3. 4. 1. 2  A d v erse E ve nt  C ollecti o n  a n d  Re p orti n g  
T he i n vesti gat or a n d s u b -i n vesti gat ors will assess o n a r o uti ne basis if a n y a d verse e ve nts o cc ur 
d uri n g t he e n d osc o pic pr oce d ure t hr o u g h t he ti me t he partici pa nt c o m pletes t he st u d y.  All  a d verse 
e ve nts/c o m plicati o ns   t hat occ ur   d uri n g t his ti me  peri o d w het her  de vi ce  relate d or   n ot will   be 
re p orte d a n d rec or d e d. 
Pre -e xisti n g c o n diti o ns t hat are prese nt  at t h e ti me of e nr ollme nt  i nt o t he cli nical st u d y will be 
c o nsi dere d c o nc urre nt me dical c o n diti o ns a n d will n ot be rec or d e d as a d v erse e ve nts  u nless t h e 
s u bject e x perie n ces  a w orse ni n g or c o m plicati o n  of s uc h a c o n c urre nt  c o n diti o n, i n w hic h  case t he 
a d verse e v e nt will  be rec or de d a n d e val uate d  b y t he i n vesti gat or. 
Patie nts will be cl osel y m o nit ore d i n a rec o v er y r o o m setti n g. All a vaila ble cli nical data,  i ncl u di n g 
e xa m fi n di n gs, a n d cli nical i m pressi o ns, will be m o nit ore d. T he  i n vesti g at or will e val uate a n y 
c ha n ges i n p h ysical stat us a n d will deter mi ne if t he c ha n ge is  cli nicall y i m p orta nt a n d differe nt 
fr o m w hat is a ntici pate d i n t he c o urse of treat me nt. 
A n y e ve nts deter mi ne d b y t he PI t o be u n a ntici pat e d a d verse de vice effects  will be  re p ort e d t o t he 
re vie wi n g I R B a n d t he st u d y tea m as s o o n as p ossi ble b ut n ot m ore t ha n 1 0 w or ki n g da ys after  t he 
i n vesti gat or first lear ns of  t he eff ect.  
A n y  u na ntici pate d  a d v erse  de vi ce  effect  will  be  i m me diatel y  e val u ate d  b y  t he  S p o ns or -
i n vesti gat or. S h o ul d it be deter mi ne d t hat t he u na ntici pate d a d v erse d e vice effect prese nts a n 
u nreas o na bl e ris k t o st u d y s u bjects, t he st u d y or t he part(s) of t he st u d y t hat prese nts t hat ris k will 
be ter mi nate d as s o o n as p ossi ble b ut n ot later t ha n 5 w or ki n g  da ys after t he S p o ns or-i n vesti gat or 
first recei ves n otice of t he effect.  
3. 4. 2  Pr ot oc ol D e vi ati o ns  
Pr ot oc ol de viati o ns ar e d efi ne d as a n y i nci de nts i n v ol vi n g n o n -a d here nce t o t he pr ot o c ol  a n d ma y 
res ult fr o m acti o ns of t h e partici pa nt, i n vesti gat or, or staff. Pr ot oc ol de vi ati o ns will be rec or d e d 
a n d will be re p orte d t o t he re vie wi n g I R B per I R B p olic y. Pr ot oc ol  de viati o ns i nte n de d t o pr otect  
t he life  or  p h ysical w ell - bei n g  of  a  partici pa nt i n a n e mer ge nc y sit uati o n a n d a n y i nci de nce of 
fail ure t o o btai n i nf or m e d c o nse nt m ust b e re p orte d t o t he re vi e wi n g I R B as s o o n as p ossi ble b ut 
n o later t h a n 5 w or ki n g d a ys aft er  t he e mer g e nc y o cc urre d. E x ce pt f or s u c h a n e mer ge nt sit uati o n, 
c ha n ges t hat ma y affect  t he scie ntific s o u n d ness of t he i n v esti gati o nal pla n or t he ri g hts, safet y or 
welfar e of st u d y  partici pa nts,  m ust be a p pr o ve d b y t he I R B pri or t o i m ple me ntati o n. 

2 3  
 
3. 4. 3  
S p o ns or  Res p o nsi bilities  
T he  s p o ns or will  select o nl y q ualifie d  i n vesti gat ors t o partici pate  i n t he researc h st u d y a n d will 
pr o vi de i n vesti gat ors wit h a st u d y pr ot oc ol a n d t h e i nf or mati o n t h e y n ee d t o pr o perl y c o n d u ct t he 
st u d y. T he s p o ns or will als o ass ure m o nit ori n g is c o n d ucte d acc or di n g t o t he m o nit ori n g pla n. I R B 
a p pr o val of  t he st u d y m ust be o btai ne d pri or t o start of t he st u d y a n d t his d oc u me ntati o n will be 
ke pt o n file. T he  s p o ns or will  pr o m ptl y n otif y t h e I R B of a n y si g nifica nt ne w  i nf or mati o n a b o ut 
t his i n vesti gati o n. 
3. 4. 4  
I n vesti g at or Res p o nsi bilities  
I n v esti gat ors are res p o nsi ble f or c o n d ucti n g t he st u d y i n acc or da n ce wit h t he si g ne d  I n v esti gat or’s 
Letter of A gr ee me nt, t he i n vesti gati o nal pla n, a n y I R B i m p ose d  c o n diti o ns, a n d a p plica ble F D A  
re g ulati o ns f or pr ot ecti n g  t he ri g hts, safet y, a n d  welfare  of  s u bjects u n der t he i n vesti gat or’s care, 
a n d f or o btai ni n g i nf or me d c o nse nt fr o m eac h researc h p artici pa nt   pri or t o a n y  st u d y-relat e d 
pr oce d ur es. I n vesti gat ors are  als o  res p o nsi ble f or m ai ntai ni n g  c o ntr ol of t he i n vesti gati o nal de vice.  
T his earl y feasi bilit y st u d y is bei n g c o n d u cte d at V a n der bilt U ni versit y Me dical Ce nter, Nas h ville, 
T N, U S A . I n v esti gat ors ma y deter mi ne if p ote ntial s u bjects w o ul d be i ntereste d i n ta ki n g part i n 
t he i n vesti gati o n pri or t o I R B a p pr o val, b ut writte n i nf or me d c o nse nt will n ot be o btai n e d  fr o m 
st u d y partici pa nts  a n d stu d y partici pati o n  will  n ot be all o we d u ntil I R B a p pr o val is recei ve d. 
T he  i n vesti gati o nal  de vice  will  o nl y  be  use d  o n  researc h  s u bjects  wit h  t he  i n vesti gat or’s  
s u per visi o n a n d will n ot be use d o n a n y p ers o n w h o is n ot a ut h orize d u n der 2 1 C F R 8 1 2 t o recei ve 
it. 
I n v esti gat ors  will  discl ose  acc ur ate  fi na n cial  i nf or mati o n  t o  all o w  c o m plete  a n d  acc urate 
certificati o n or discl os ure state me nts t hat ma y be re q uire d. T his i nf or mati o n will be  c ollecte d via 
F D A F or ms 3 4 5 4 a n d 3 4 5 5, as a p pr o priate, a n d will be u p date d pr o m ptl y if  a n y rele v a nt c ha n ges 
occ ur d uri n g t he c o urse of t he cli nical st u d y a n d f or o ne year aft er t h e c o m pleti o n of t his st u d y. 
3. 4. 5  
Selecti o n  of I n vesti g at ors 
All cli nical i n vesti gat ors ta ki n g part i n t his st u d y are acc o m plis he d gastr o i ntesti nal e nd osc o pists 
w h o  c o m m o nl y perf or m  e n d osc o pic pr o ce d ures as part of t heir practice . All u n dersta n d a n d will  
c o m pl y wit h  t heir res p o nsi bilities re gar di n g a d h ere nce t o t he a p pr o ve d pr ot oc ol a n d t he si g ne d 
I n v esti gat or’s Letter of A gree me nt.  T he  researc h pr ot oc ol will  ta ke place  at Va n der bilt U ni versit y  
Me dical  Ce nter  wit h  the principal i n vesti gat or ( PI) b ei n g Dr. Keit h L. O bstei n . His  c urric ul u m vit ae is 
i ncl u de d i n A p pe n di x C . 
3. 4. 6  
I nf or m e d C o nse nt  
O nce a p ote ntial st u d y s u bject has bee n i de ntifie d, a me m ber of t he researc h tea m will  prese nt t he 
researc h st u d y t o t he s u bject i n pers o n, via p h o n e, or via s ec ure electr o ni c tra nsfer (e. g. s ec ure 
e mail or M y Healt h at Va n der bilt electr o nic p ortal). T he p ote ntial  partici p a nt will be pr o vi de d wit h 
a c o p y of t he c o nse nt f or m t o rea d a n d will be pr o vi de d  wit h a n o p p ort u nit y t o as k q uesti o ns. O nce 
t he st u d y partici pa nt’s q uesti o ns ha ve bee n a ns w ere d a n d pri or t o perf or mi n g a n y st u d y -relate d 
pr oce d ur e, a n I R B -a p pr o ve d c o nse nt  for m  will  be si g ne d a n d date d  b y t he st u d y partici pa nt  a n d b y 
t he pers o n o btai ni n g i nf or me d c o nse nt. A c o p y of t he si g ne d c o nse nt f or m will  be pr o vi de d t o t h e 
s u bject a n d  t he i nf or me d c o nse nt pr ocess will  be d oc u me nte d i n  t he st u d y partici pa nt’s  me dical 
rec or d. 

2 4  
 
3. 5  
Refere nces  
Please  see t he f o ot n otes t hr o u g h o ut a p plicati o n. 
 
4.  RI S K  A N A L Y SI S  
4. 1  Descri pti o n,  A n al ysis, a n d Miti g ati o n of Ris ks  
T here ar e i n her e nt ris ks c o m m o n t o all e n d osc o pic pr oce d ure s. T hese ris ks are n ot u ni q ue t o t his 
rese arc h  a n d are liste d i n t he ta ble bel o w.   
T a bl e 3 . Ris k A n al ysis a n d  Miti g ati o n  
Ris ks  w hic h are  N O T U NI Q U E t o  t his rese arc h 
P ote nti al  
H az ar d  
Res ult a nt  H ar m  
Ris k  A n al ysis Disc ussi o n  a n d Miti g ati o n Str ate g y  
E n d osc o pic 
pr oce d ure  
Risks i ncl u de b ut are 
n ot li mite d  t o 
blee di n g, i nfecti o n, 
a n d/ or nee d f or 
a d diti o n al s ur gery. 
St a n d ar d of c are f or p atie nts wit h F A P is t o  u n der g o a 
r o uti ne e n d osc o pic ex a mi n ati o n of t he m uc os al li ni n g t o 
assess p oly p f or m ati o n  every 1 ye ar f or c ol o n osc o py a n d 
every 2-3 ye ars f or u p per e n d osc o py . T he  s ur gic al risks 
descri be d are n o gre ater f o r patie nts receivi n g t he 
i nvesti g ati o n al pr oce d ure t h a n f or st a n d ar d of c are 
pr oce d ures f or t his p o p ul ati o n. P atie nts will  be  c o u nsele d 
a b o ut  t hese risks. 
M o nit ore d 
A nest hesi a 
C are ( M A C)  
Risks of a nest hesi a 
i ncl u de b ut are n ot 
li mite d t o str oke a n d 
de at h.  
T he risks descri be d are n o gre ater f or  p atie nts receivi n g t he 
i nvesti g ati o n al pr oce d ure t h a n tr a diti o n al  ex a mi n ati o n. 
P atie nts will be  c o u nsele d  a b o ut t hese risks. 
 
T here als o ris ks w hic h are u ni q ue t o t his rese arc h . T hese ris ks, al o n g wit h desi g ne d a n d 
i m ple me nte d ris k c o ntr ols are liste d i n t he ta ble bel o w. A n i n-de pt h disc ussi o n of eac h of t hese 
u ni q ue ris ks a n d t he i m ple me nte d ris k c o nt r ols t o miti gate t hese ris ks f oll o ws t he ta ble.  
T a bl e 4 . Ris k A n al ysis a n d Miti g ati o ns ( u ni q u e t o t his r e s e ar c h). 
Ris ks  w hic h are U NI Q U E t o  t his rese arc h 
P ote nti al  
H az ar d  
Res ult a nt  H ar m  
Ris k  A n al ysis Disc ussi o n  a n d Miti g ati o n Str ate g y  
Device 
Det ac h me nt 
fr o m t he 
e n d osc o pe 
w hile 
de pl oye d i n 
t he p atie nt 
Sli g ht del ay i n 
p atie nt c are d ue t o 
device retriev al  
Dist al e n d osc o pe att ac h me nt devices d o h ave a s m all c h a nce 
of device det ac h me nt fr o m t he e n d osc o pe. O ur revie w of t he 
M A U D E d at a b ase f or ot her dist al e n d osc o pe att ac h me nt 
devices s h o ws t h at eve n w he n t he device d oes det ac h fr o m t he 
e n d osc o pe it d oes n ot c a use h ar m t o t he p atie nt ( see M A U D E 
d at a i n A p pe n dix A ).  If t he device d oes det ac h d uri n g use, 
the device is retrieve d usi n g e n d osc o pic t o ols s uc h as a R ot h 
net or a n alli g at or f orce ps as is st a n d ar d pr actice f or 
retriev al of f orei g n b o dies i n t he g astr oi ntesti n al tr act. 
P atie nts will be c o u nsele d a b o ut t hese risks.  F or m ore 
i nf or m ati o n re g ar di n g t his risk ple ase see a det aile d 
disc ussi o n here.  
N o n -
bi oc o m p ati ble 
m ateri al use d 
Aller gic re acti o n  
All m ateri als a n d a d hesives use d i n t he device c o nstr ucti o ns 
are bi oc o m p ati ble. Ple ase refer t o A p pe n dix B  f or 
bi oc o m p ati bility i nf or m ati o n/testi n g certific ates. We h ave 

2 5  
 
i n t he device 
deter mi ne d t h at bec a use all m ateri als use d i n t he device are 
bi oc o m p ati ble a n d h ave bee n teste d t o t he a p pr o pri ate I S O 
1 0 9 9 3 st a n d ar d t h at t he risks ass oci ate d wit h 
bi oc o m p ati bility are acce pt a ble a n d d o n ot p ose seri o us risk 
t o t he he alt h, or welf are of t he s u bject.  P atie nts will be 
c o u nsele d a b o ut t hese risks. F or m ore i nf or m ati o n re g ar di n g 
t his risk ple ase see a det aile d disc ussi o n here.  
N o n -sterile 
N u Vie w 
device use d  
P atie nt i nfecti o n  
M ateri als h ave bee n selecte d wit h t he pr o p ose d steriliz ati o n 
pr ocess i n mi n d. All m ateri als use d i n t he c o nstr ucti o n of t he 
device h ol d u p well t o a ut ocl ave steriliz ati o n. T he s afety a n d 
verific ati o n d at a perf or me d o n t he device as p art of t his 
a p plic ati o n w as perf or me d p ost steriliz ati o n t o give 
c o nfi de nce t h at t he device c a n be sterilize d a p pr o pri ately. 
F urt her, e n d osc o py wit hi n t he GI is c o nsi dere d a cle a n-
c o nt a mi n ate d ty pe pr oce d ure, me a ni n g t h at w hile t he device 
is p ack a ge d sterile, t he e nvir o n me nt itself is n ot sterile. 
Sterility will be m ai nt ai ne d per t he st a n d ar d of c are.  P atie nts 
will be c o u nsele d a b o ut t hese risks.  F or m ore i nf or m ati o n 
re g ar di n g t his risk ple ase see a det aile d disc ussi o n here.  
Device 
pr ojecti o ns 
bre ak a ge  
Sli g ht del ay i n 
p atie nt c are d ue t o 
retriev al 
We h ave ex a mi ne d t he M A U D E d at a b ase f or device 
bre ak a ges f or  a si mil ar ty pe device a n d o ne of t he m ost 
c o m m o nly see n device f ail ures f or t his ty pe of device is t h at 
of pr ojecti o n bre ak a ges ( See M A U D E d at a i n A p pe n dix A ). 
We h ave t ake n t his i nt o acc o u nt d uri n g t he desi g n of t he 
device a n d h ave cre ate d re d u n d a ncy t hr o u g h t he a d diti o n of 
a s afety l o o p s o t h at e ac h pr ojecti o ns nee ds at le ast t w o 
i n de pe n de nt bre ak a ges f or a ny o ne pr ojecti o n t o bre ak off 
fr o m t he device. Si mil arly, we h ave desi g ne d o ut t he t hi n pi n-
j oi nt f ail ure z o ne w hic h we believe c o ntri b utes t o t he 
m aj ority of t he bre ak a ges f or t he Arc E n d oc uff device t h at 
o ur N u Vie w device is desi g ne d after. T o get her, t hese 
activities h ave le d us t o deter mi ne d t h at t his risk h as bee n 
miti g ate d t o a n acce pt a ble level t hr o u g h t he i m ple me nte d risk 
c o ntr ols a n d as s uc h d oes n ot p ose seri o us risk t o t he he alt h, 
or welf are of t he s u bject.  P atie nts will be c o u nsele d a b o ut 
t hese risks. F or m ore i nf or m ati o n re g ar di n g t his risk ple ase 
see a det aile d disc ussi o n here.  
Irri g ati o n 
a n d/ or 
ill u mi n ati o n 
bl ock a ges  
Sli g ht del ay i n 
p atie nt c are  
We h ave miti g ate d t his risk t hr o u g h i n here nt desi g n, h avi n g 
m a de t he press fitti n g att ac h me nt fe at ure s uc h t h at it will 
o nly c o me i nt o c o nt act wit h t he si de pr ofile of t he e n d osc o pe 
a n d will st ay sec urely i n pl ace wit h o ut c overi n g t he fr o nt f ace 
of t he e n d osc o pe w here t he s ucti o n a n d irri g ati o n c h a n nels 
are l oc ate d. F urt her we h ave i nc or p or ate d a dr ai n a ge h ole 
l oc ate d i n t he b ack b o ne of t he device t o ai d i n irri g ati o n. We 
h ave als o r u n verific ati o n tests t o e ns ure t h at irri g ati o n 
a n d/ or ill u mi n ati o n h ave bee n m ai nt ai ne d.  F or m ore 
i nf or m ati o n re g ar di n g t his risk ple ase see a det aile d 
disc ussi o n here.  
Tr a u m atic 
fe at ures, 
Tiss ue tr a u m a  
We h ave desi g ne d t he N u Vie w usi n g a s oft, flexi ble, 
bi oc o m p ati ble m ateri al t h at s h o ul d re d uce tiss ue tr a u m a. We 

2 6  
 
s h ar p e d ges, 
M axi m u m 
i nserti o n 
wi dt h  
h ave i ncl u de d a n atr a u m atic i nserti o n ti p wit h a n  atr a u m atic 
pr ofile fe at uri n g a s m o ot h r o u n de d d o me. We h ave als o 
r o u n de d all ex p ose d e d ges o n t he device i n acc or d a nce wit h 
h u m a n f act ors H E -7 5 g ui d a nce t o f acilit ate m ore atr a u m atic 
i nserti o n a n d we h ave desi g ne d t he device i n acc or d a nce f or 
m axi m u m i nserti o n wi dt h i n acc or d a nce wit h t he 
i nter n ati o n al e n d osc o pe st a n d ar d I S O- 8 6 0 0. We h ave 
deter mi ne d t h at w hile tiss ue tr a u m a is a n i n here nt risk t o all 
dist al e n d osc o pe att ac h me nt ty pe devices s uc h as t he 
N u Vie w, t his risk h as bee n miti g ate d t o a n acce pt a ble level 
t hr o u g h t he i m ple me nte d risk c o ntr ols a n d as s uc h d oes n ot 
p ose seri o us risk t o t he he alt h, or welf are of t he s u bject.  
P atie nts will be c o u nsele d a b o ut t hese risks.  F or m ore 
i nf or m ati o n re g ar di n g t his risk ple ase see a det aile d 
disc ussi o n here.  
 
De vice det a c h m e nt ris k miti g ati o ns:  
U ni nte nti o nal de vice d et ac h me nt fr o m t he e n d os c o pe is c urre ntl y t h e m ost pr o ba ble ris k f or t h e 
N u Vie w d e vice. If a n u ni nte nti o nal detac h me nt ha p pe ns bef ore t he d e vi ce is i nserte d i nt o t he 
patie nt t here is n o ris k t o t he patie nt or us er. T h e user w o ul d si m pl y nee d t o o pe n a n d attac h a ne w 
N u Vie w de vice a n d t he n i nsert t he e n d osc o pe wit h attac he d N u Vie w d e vice n or mall y. If t h e 
u ni nte nti o nal detac h me nt ha p pe ns aft er t he e n d os c o pe has bee n i ns erte d i nt o t he patie nt,  t he de vice 
will nee d t o be retrie ve d bef ore t he pr o ce d ure ca n c o nti n ue. Base d o n o ur re vie w of t he M A U D E 
data base f or si milar distal e n d osc o pe attac h me nt t y pe de vices, u ni nte nti o nal de vice detac h me nt 
wit hi n  t he  patie nt  is  t he  m ost  
c o m m o n a d vers e e ve nt r e p orte d 
f or t his t y pe of d e vice. W hile t he 
m ost 
c o m m o n,  it  d oes  n ot  
a p pear t o be a si g nifica nt ris k t o 
t he patie nt. Wit hi n o ur re vie w of 
t he
 M A U D E
 data base,
 
u ni nte nti o nal detac h me nt wit hi n 
t he  patie nt  w as  re p ort e d  2 4  
ti mes. N o ne of t hese d etac h me nt 
e ve nts  res ulte d  i n  har m  t o  t he 
patie nt. I nstea d, t he y r e p orte d a 
sli g ht  dela y  t o  t he  pr oce d ures  
d ue t o t he de vi ces nee di n g t o be 
retrie ve d 
b y
 a
 mi ni mall y
 
i n vasi ve
 met h o d
 s uc h
 as
 
t hr o u g h t he use of a R ot h net 
(Fi g ure  2 ) i n li ne wit h A S G E f orei g n b o d y  re m o val g ui deli nes here .   F or m ore details o n t he 
M A U D E data b ase re p orts relati n g t o de vice detac h me nt f or si milar t y pe de vices t o t he N u Vie w 
de vice ( a n d h o w we use d t his i nf or mati o n t o dri ve a p pr o priate ris k c o ntr ols d uri n g t he desi g n a n d 
de vel o p me nt pr ocess) p lease refer t o A p p e n di x A . 
We ha ve miti gate d t his ris k of u ni nte nti o nal detac h me nt i n part b y desi g n c ha n ges t o t he N u Vie w 
de vice’s press fitti n g feat ure. We ha v e u n d ersize d t his press fitti n g t o i ncreas e t he f orce wit h w hic h 
Fi g ur e 2 . R ot h n et us e d f or f or ei g n b o d y r etri e v al wit hi n t h e GI tr a ct. 

2 7  
it attac hes t o t he e n d osc o pe. C urre ntl y t he e n d osc o pe is 9. 9 m m i n dia meter w hile t he N u Vie w 
press fitti n g a n u n dersize d 9. 2 5 m m. T he N u Vie w ca n still fit o n t he e n d osc o pe easil y e ve n t h o u g h 
it is u n dersize d d ue t o t he bi oc o m pati ble elastic material t hat it is c o nstr ucte d fr o m. T his material 
is i deal f or t he pr ess fitti n g d ue t o its hi g h resilie nce, e xcelle nt stretc h a n d c o m pressi o n pr o perties, 
a n d te nsile str e n gt h. F or a f ull c haract erizati o n of t his material pleas e refer A p p e n di x B . T h ese 
material pr o perties all o w t he press fitti n g t o ti g htl y a n d sec urel y fit o nt o t he e n d osc o pe, w hile still 
bei n g s oft a n d fle xi ble s o as n ot t o da ma ge t he e n d osc o pe itself. T he m aterial is als o bi oc o m pati ble 
a n d easil y sterilize d h a vi n g bee n teste d t o t h e i nter nati o nal I S O-1 0 9 9 3 bi oc o m pati bilit y sta n dar d 
a n d s h o w n t o mai ntai n material pr o perties r o b ust n ess after c o m m o n sterilizati o n met h o ds s uc h as 
a ut ocla ve  sterilizati o n,  ga m ma  sterilizati o n,  e -b ea m  sterilizati o n,  a n d  Et h yle ne  O xi de  ( Et O)  
Sterilizati o n  (refer t o A p pe n di x B  f or bi oc o m pati bilit y a n d sterilizati o n data/re p orts).   
T he N u Vi e w h as als o u n der g o ne be nc h a n d usa bilit y testi n g t o ai me d at assessi n g a n d e ns uri n g 
t hat t he N u Vie w mai ntai ns attac h me nt t o t he e n d osc o pe. T he f oll o wi n g is a brief s u m mar y of t h e 
i nter nal be n c h a n d user t esti n g c o m plete d t o verif y t hat t he N u Vie w will mai ntai n attac h me nt t o 
t he e n d osc o pe.  
a.
Stre n gt h of att ac h me nt assess me nt:
We ha ve c h aracterize d t he f orce re q uire d t o re m o v e t he N u Vie w fr o m t he e n d osc o pe . T he
detac h me nt f or ce was meas ure d b y pr o perl y affi xi n g t he N u Vie w de vice t o t he e n d osc o pe
ti p a n d m o u nti n g t he e n d osc o pe t o t he 3 D pri nte d detac h me nt f orce ji g. T he test set u p f or
t his e x peri me nt ca n b e see n i n t he fi g ure b el o w.
T he N u Vie w w as m o u nte d i nt o a cla m p a n d a l oa d cell was attac h e d t o t he cla m p o n o ne 
si de a n d a m ot or o n t he ot her si de. T he m ot or w as pr o gra m me d t o retract u ntil t he N u Vie w 
beca me f ull y d etac h e d fr o m t he e n d osc o pe a n d t he detac h me nt f orce w as rec or de d.  T o 
e ns ure  e n d os c o pe  attac h me nt  r o b ust ness  ei g ht  differe nt  N u Vie w  de vices  were  
attac he d/ detac he d fr o m t he e n d osc o p e ti p at least 1 5 ti mes eac h. T hr o u g h t hese tests, it was 
f o u n d t hat an a v era g e  detac h me nt f orce of 9. 6 4 N acr oss all e x peri me nts a n d mi ni m u m 
detac h me nt f orce of 7. 9 2 N was  re q uire d t o f ull y d etac h t he N u Vie w fr o m t he gastr osc o p e. 
E n d osc o pe  
N u Vie w  Ca p  
M ot orize d 
Sta ge  
L oa d Cell  
E n d osc o pe 
Cla m p  
N u Vie w Cla m p  
Fi g ur e 3 . E x p eri m e nt al s et u p f or a c c e ssi n g f or c es r e q uir e d t o d et a c h t h e N u Vi e w d e vi c e fr o m t h e e n d os c o p e.  

2 8  
T his re m o val f or ce gr eatl y e xcee ds t he e x p ecte d  f orces o n t he N u Vie w w h e n de pl o ye d i n 
t he patie nt gi vi n g c o nfi d e nce t hat t h e de vice will n ot u ni nte nti o nall y detac h d uri n g t he 
pr oce d ur e. N o s yste mic  de vice fail ures or brea ka ges were o bser ve d i n t he se e x peri me nts . 
T he o nl y n o n perf or ma n ce o bser ve d i n t h ese e x peri me nts  was t h at o ne of t he  press -fit 
c ollars f or a si n gle de vi ce start e d t o s h o w a d hesi ve fail ure o n t he 1 5 t h ti me of bei n g 
reattac h e d a n d u nattac he d fr o m t he e n d osc o pe. We belie ve t his was i n part d ue t o t he 
e x peri me ntal set u p, w her e hi g her a n d re p eate d stress was place d o n t his sea m t ha n w o ul d 
be see n i n cli nical use w here t h e p h ysicia n w o ul d attac h t he de vi ce o n ce a n d t he n re m o ve 
t he de vice o nce at t he e n d of t he pr oce d ure. I n t otal, of t he 1 2 0 attac h me nt/ detac h me nts 
perf or me d o nl y o ne si n gle de vice s h o w e d a  si n gle a d hesi ve iss ue o n t h e last of t he  1 5 
attac h me nt/ detac h m e nt r u ns. Of all t he ot h er de vi ces teste d, n o fail ure was detecte d; t his 
e nforces t he ass u m pti o n t hat t his fail ure was a o ne -off test set u p or ma n ufact uri n g fail ure. 
D uri n g a n act ual pr oce d ure, w e e x p ect t he N u Vie w t o be attac he d o nce at t he be gi n ni n g of 
t he  pr oce d ure  a n d  t he n  detac he d  fr o m  t he  e n d osc o pe  o nce  u p o n  c o m pleti o n  of  t he 
pr oce d ur e. T his dat a gi ves c o nfi de nce t hat t he e n d osc o pe attac h me nt press fitti n g is m ore 
t ha n s ufficie ntl y r o b ust.  
T a bl e 5 . S u m m ar y of t h e f or c es r e q uir e d t o d et a c h t h e N u Vi e w fr o m t h e e n d os c o p e 
b.
C o m p ari n g det ac h me nt f orces t o a n F D A a p pr ove d dist al e n d osc o pe att ac h me nt device:
We ha v e c o m p are d t he f orce re q uire d t o re m o v e t he N u Vie w fr o m t he E n d osc o pe t o a n
F D A a p pr o ve d distal e n d osc o pe attac h me nt de vice si milar t o t he N u Vie w, calle d t he Arc
E n d oc uff . T his is t o e ns ure t hat t he N u Vie w de vice is at least as s afe fr o m detac h me nt
e ve nts as t he Ar c E n d oc uff. T he det ac h me nt f orce was meas ure d b y attac hi n g t he Arc
E n d oc uff t o a n e n d os c o p e a n d p ulli n g it off t he e n d osc o pe usi n g a cali brat e d f orce ga u ge
si milar t o h o w t he N u Vie w detac h m e nt f orces w ere c h aracterize d. T hr o u g h t hese tests, it
was f o u n d t hat a n a v er a ge detac h me nt f orce of 8. 9 N  a n d mi ni m u m f orce of 6. 4 N  is
re q uire d t o f ull y detac h t he Arc E n d oc uff fr o m t h e e n d osc o p e. A s u m mar y of t he f orces
re q uire d t o r e m o ve t he Arc E n d oc uff fr o m t he e n d osc o pe ca n b e see n i n t he ta ble bel o w.
     T a bl e 6 . S u m m ar y of t h e f or c e r e q uir e d t o d et a c h t h e Ar c E n d o c uff ( F D A a p pr o v e d d e vi c e) 
De vice  
A ver a ge F orce [ N]  Mi n F orce [ N]  M a x F orce [ N]  
1  
9. 4 6  
8. 7 2  
1 0. 2 3  
2  
9. 5 0  
9. 0 0  
1 0. 4 0  
3  
8. 2 2  
7. 9 2  
8. 6 5  
4  
1 0. 1 9  
9. 3 0  
1 1. 9 1  
5  
1 0. 1 0  
9. 5 6  
1 1. 6 5  
6  
9. 9 6  
8. 9 5  
1 0. 6 4  
7  
9. 5 4  
8. 6 9  
1 0. 2 0  
8  
1 0. 0 9  
9. 5 8  
1 0. 7 9  
Over all aver a g e:  
9. 6 4  
8. 9 7  
1 0. 5 6  
De vice  
A ver a ge F orce [ N]  Mi n F orce [ N]  M a x F orce [ N]  
1  
1 1. 3 6  
9. 6 0  
1 4. 6 0  
2  
7. 1 4  
6. 4 0  
8. 4 0  
3  
8. 8 8  
7. 8 0  
1 1. 2 0  
4  
8. 1 6  
7. 0 0  
9. 0 0  

2 9  
T his e x peri me nt de m o nstrates t hat t he mi ni m u m N u Vie w detac h me nt f orce e x cee ds t he 
mi ni m u m a vera ge f orce of t he E n d o c uff, i n dicati n g t hat t he N u Vie w is less li kel y t o detac h 
fr o m t he e n d osc o p e w he n c o m pare d t o a v er y si milar F D A a p pr o ve d d e vice. 
c.
Assessi n g cli nic ally relev a nt f orces pl ace d o n t he N u Vie w i n a p orci ne c ol o n m o del:
T he fi nal test t o e ns ure t h at t he N u Vie w’s attac h me nt t o t he e n d osc op e is s ufficie nt l y r o b ust
was perf or m e d usi n g a p orci ne c ol o n si m ulate d use e x peri me nt. T his e x peri me nt meas ure d
t he cli nicall y rele va nt f orces t h e d e vice w o ul d e x perie nce d uri n g i nserti o n a n d re m o val
fr o m t he c ol o n. We attac he d t he N u Vie w t o a n e n d osc o pe a n d t he n c o nti n u o usl y meas ure d
t he f orces t hat t he de vice face d d uri n g i nserti o n a n d re m o val fr o m t he p orci ne c ol o n b y
usi n g a l oa d cell c o n n ecte d t o t he gastr os c o pe  d uri n g i nserti o n a n d re m o val i nt o t he p orci n e
c ol o n. T his e x peri me nt was re peate d 1 0 ti mes. T hr o u g h t his e x peri me nt, we meas ure d a
retracti o n f orce 2. 5 N  +/ - 1 N. T his retracti o n f orce d uri n g use is s u bsta ntiall y less t ha n t he
mi ni m u m N u Vie w detac h me nt f orce  ( 7. 9 2 N) meas ure d i n Test 1, mea ni n g t he N u Vie w is
n ot li kel y t o detac h fr o m t he e n d osc o pe t hr o u g h t h e c o urse of a n or m al pr oce d ure.
Ris k s u m m ary: We h ave deter mi ne d t h at w hile det ac h me nt is a n i n here nt ris k t o all dist al 
e n d osc o pe att ac h me nt ty pe devices s uc h as t he N u Vie w, t his ris k h as bee n miti g ate d t o a n 
acce pt a ble l evel t hr o u g h t he i m ple me nte d ris k c o ntr ols a n d as s uc h d oes n ot p ose ser i o us ris k 
t o t he he alt h, or welf are of t he s u bject.  
N o n -bi oc o m p ati bilit y ris k miti g ati o ns:  
All materials use d i n t he N u Vie w ar e bi oc o m pati ble. T he ris ks s urr o u n di n g bi oc o m pati bilit y f or 
me dical  de vices  ar e  well  u n derst o o d  a n d  t he  F D A  h as  e xcelle nt  bi oc o m pati bilit y  g ui da nce  
d oc u me nts . Si milarl y, t here are rec o g ni ze d i nter n ati o nal sta n dar ds s urr o u n di n g bi oc o m pati bilit y 
s uc h as I S O 1 0 9 9 3- 1.   
We ha ve ta k e n t he ris k of bi oc o m pati bilit y i nt o acc o u nt i n t he de vel o p me nt of t he N u Vie w de vice. 
T he de vice is ma de fr o m 1 0 0 % bi oc o m pati ble materials f or piece of t he de vice. Bel o w is a list of 
all materials use d i n t he de vice, i ncl u di n g a n y a d hesi ves, 3 D resi ns, or ot h er materi als 
C ar b o n I nc.’s Sil 3 0 pri nt a ble resi n : T he press-fit c ollar will be ma de fr o m Car b o n In c.’s SI L 3 0 
material w hic h is a s oft, bi oc o m pati ble, silic o n e uret ha ne elast o mer t hat has u n der g o ne I S O - 1 0 9 9 3 
testi n g f or s ki n a n d m uc osal me m bra ne c o ntact. T he press -fit c ollar will be ma de fr o m t his s oft, 
elastic, silic o ne uret ha n e elast o mer  i n or der t o s afel y i nteract wit h tiss ue d uri n g F A P. T his s oft 
silic o ne uret ha n e el ast o mer ( SI L 3 0) has u n der g o ne ri g or o us bi o c o m pati bilit y/sterilit y testi n g 
w hic h ma kes it i deal f or s h ort ter m m uc osal m e m bra ne c o ntact ( u p t o 2 4 h i n d urati o n). See 
A p pe n di x B  f or a d diti o nal details relati n g t o bi oc o m pati bilit y a n d sterilit y.      
F or ml a bs’s Me dic al Gr a de T o u g h 1 5 0 0 R esi n: T o u g h 1 5 0 0 material has bee n teste d t o I S O - 1 0 9 9 3 
bi oc o m pati bilit y sta n dar d (see A p p e n di x B ). T his material c urre ntl y ma kes u p t he N u Vie w’s b o d y 
a n d bac k b o ne. It is a n e x celle nt material f or t h e t his beca use of it’s stiff, yet plia ble nat ure bei n g 
a ble t o be n d a n d s pri n g bac k q uic kl y t o its ori gi nal s ha pe. Si milarl y, t his material is c o m pati ble 
wit h a wi de ra n ge of c o m m o n sterilizati o n pr ocesses f or me dical de vices. F or m ore i nf or mati o n 
o n t his material, i ncl u di n g bi oc o m pati bilit y a n d sterilit y i nf or mati o n please refer t o A p pe n di x B .  
Mirr or:  T he mirr or is ma de fr o m 1 m m -t hic k mirr ore d gl ass. T his c o m p o ne nt will be c ust o m-
Over all aver a g e:  
8. 9  
7. 7  
1 0. 8  

3 0  
 
ma n ufact ur e d b y K ni g ht O ptical usi n g a scri bi n g pr ocess. U p o n d eli ver y t o E n d o T heia, t he mirr or 
will be clea ne d usi n g 9 9 % is o pr o p yl alc o h ol pri or t o asse m bl y.  
A d hesive i nf o : L octite 4 3 5 h u mi dit y -c ure d et h yl -base d  a d hesi ve fr o m He n kel has bee n teste d t o 
I S O-1 0 9 9 3 bi o c o m pa bilit y sta n dar d (see A p pe n di x B ). T his a d hesi ve is use d t o faste n t he press -
fitti n g feat ure wit h pr ojecti o ns a n d t he mirr or t o t he str uct ural b o d y of t h e N u Vie w. Si milarl y, t his 
a d hesi ve is c o m p ati ble wit h a wi de r a n ge of c o m m o n sterilizati o n pr ocess es f or m e dical d e vices, 
s uc h  as  c ol d  sterila nts,  et h yle ne  o xi de,  a n d  ga m ma  ra diati o n.  F or  m ore  i nf or mati o n  o n  t his  
material, i ncl u di n g bi oc o m pat i bilit y a n d sterilit y i nf or mati o n please refer t o A p pe n di x B . 
Ris k s u m m ary: We h ave deter mi ne d t h at bec a us e all m ateri als use d i n t he c o nstr ucti o n a n d all 
a d hesives  use d  d uri n g  device  asse m bly  are  bi oc o m p ati ble  a n d  h ave  bee n  teste d  t o  t he  
a p pr o pri ate I S O 1 0 9 9 3 st a n d ar d t h at t he ris ks ass oci ate d wit h bi oc o m p ati bility are acce pt a ble 
a n d d o n ot p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.  
 
 
Sterilit y r is k miti g ati o ns: 
Sterilizati o n ris ks are i n here nt t o all me dical de vices. B ot h t he ris ks ass ociate d wit h i nfecti o n w he n 
de vices  ar e  n ot  sterilize d  a n d  t he  ris ks  ass ociate d  wit h  material  pr o pert y  de gra dati o n  if  a n  
i na p pr o priate sterilizati o n met h o d is c h ose n f or a gi ve n material. We ha ve ta ke n b ot h of t hes e 
p ote ntial ris k cate g ories i nt o acc o u nt d uri n g t he de vel o p me nt of t he N u Vie w de vice.  
We ha v e i ncl u de d i nf or mati o n i n  A p pe n di x B  wit h re gar ds t o sterilit y s h o wi n g h o w a n i n de p e n de nt 
sterilit y testi n g h o use ( S T E RI S) has verifie d t hat a ut ocla ve is a n a p pr o priate met h o d of sterilizati o n 
of b ot h of t he F or mla bs’s resi ns we’ ve us e d i n t he c o nstr ucti o n of t he de vice. Si milarl y, t he me dical 
gra de  a d hesi v e  we’ v e  use d  d uri n g  t he  asse m bl y  pr ocess  has  s h o w n  t o  be  resilie nt  u p  t o  
te m perat ur es m uc h hi g her t ha n t h ose see n i n t he a ut ocla vi n g pr ocess a p pr o priate f or t he N u Vie w 
(A p pe n di x B  f or data o n a d hesi ve). We ha v e als o verifie d t hat t his a d hesi ve mai ntai ns its pr o perties 
a n d f u ncti o nal str e n gt h s ufficie nt p ost sterilizati o n . All materials use d i n t he c o nstr ucti o n a n d 
asse m bl y are a p pr o priate materials f or o ur sel ecte d sterilizati o n pr ocess of a ut ocla vi n g a n d all of 
t he materials s h o w resilie nce t o t he a ut ocla vi n g sterilizati o n pr ocess. Please refer t o A p pe n di x B  
t o see t he resilie nce of s electe d mat erial a n d t he a p pr o priate n ess of t he a ut ocla vi n g sterilizati o n 
pr ocess.  
Ris k s u m m ary: We h ave deter mi ne d t h at t he ris ks ass oci ate d wit h sterility a n d t he steriliz ati o n 
pr oc ess are c urre ntly acce pt a ble a n d d o n ot p ose seri o us ris k t o t he he alt h, or welf are of t he 
s u bject.  
 
 
De vice bre a k a ge & f ail ure r is k miti g ati o ns:  
A n ot her ris k i n her e nt t o me dical de vices is t he ris k of de vice brea k a ges or fail ures. I n d ee d, a l ar g e 
part of t he de vel o p me nt pr ocess is ai me d at i de ntif yi n g a n d miti gati n g p ote ntial de vice brea k a ges 
a n d fail ure p oi nts. Lar g e eff orts are ma d e t o i de ntif y t hese p ossi ble  brea k a ges t hr o u g h a s yste matic 
pr ocess s uc h as Fail ure M o des & Effects A n al ysis ( F M E A) a n d Fa ult Tree A nal ysis ( F T A). As 
part of o ur de v el o p me nt pr ocess,  w e e m pl o y b ot h of t hese m et h o ds f or i de ntif yi n g p ote ntial de vice 
fail ures a n d br ea ka g es. A n ot her wa y de vi ce de v el o pers tr y t o i de ntif y p ote ntial fail ure m o des or 
li kel y brea ka ges is t o researc h w h at t he fail ures a n d brea ka g es are re p orte d i n t he F D A’s M A U D E 
data base f or ot her si milar t y pe de vices. We h a ve re vie we d t his M A U D E data base dat a f or d e vice 

3 1  
brea k a g es a n d fail ures f or de vices si milar t o t he N u Vie w (refer t o A p pe n di x A ) a n d t he n ta ke n t his 
i nf or mati o n  i nt o  acc o u nt  d uri n g  desi g n  t o  create  ris k  c o ntr ols  t o  pre ve nt  si milar  t y pe  of  
fail ures/ brea ka g es fr o m h a p pe ni ng d uri n g use of t h e N u Vie w d e vice.  
O ne of  t he m ost c o m m o nl y see n de vice brea ka g es re p orte d i n t he M A U D E data bas e f or distal 
e n d osc o pe attac h me nt t y pe de vices is t hat of pr oj ecti o n brea k a ges. T hes e e n dca ps ha v e hairli ke 
pr ojecti o ns t hat ar e mea nt t o s m o ot h o ut t he m uc osal f ol ds a n d i ncreas e e n d osc o pe vis ualizati o n. 
T hese hairli ke pr oj ecti o ns ca n be see n i n t he fi g ure bel o w. T hese pr ojecti o ns are i nte n de d t o f ol d 
bac k d uri n g e n d osc o pe i nserti o n a n d t he n t o fa n o ut war ds a n d i nteract wit h t he m uc osal tiss ue as 
y o u ge ntl y p ull t he e n d osc o pe bac k war ds. D uri n g t his i nteracti o n wit h t he m uc osal li ni n g, t he y 
b ot h s m o ot h t he f ol de d tiss ue a n d als o kee p t he tiss ue sli g htl y a wa y fr o m t he e n d osc o pe’s ti p s o 
t hat t he tiss ue is at t he pr o per vie wi n g dista nce fr o m t he e n d osc o pe o ptic or vie wi n g le ns. T hese 
h airli ke pr ojecti o ns are als o pr o ne t o brea ki n g off fr o m t he de vice d ue t o t heir sli m pr ofile a n d 
pi n p oi nt c o n necti o ns t o t he b o d y of t he de vi ce. F or e xa m ple, t here were  s e veral differe nt re p orts 
of t his t y pe of de vice br ea ka g e re p orte d i n t he M A U D E data b as e f or t h e arc E n d oc uff de vi ce 
(K 1 5 1 8 0 1 ). T he bel o w ta ble lists a fe w e x a m ples  re p orts f or h airli ke pr ojecti o n brea ka g es f or t h e 
Arc E n d oc uff a n d t h ere are li n ks wit hi n t he ta ble t o t he f ull re p orts.  
T a bl e VII . M A U D E D at a (fr o m t h e F D A d at a b as e) 
M A U D E D A T A: E x a m ple re p orts f o r h airli ke pr ojecti o n bre a k a ges  
De vice  
D ate  
Pr o ble m  
Descri pti o n  
H ar m  
K 1 5 1 8 0 1  
1 2/ 0 9/ 2 0 1 5   Detac h me nt
 of
 
de vice c o m p o n e nt  
De v ice detac h es fr o m t h e 
e n d osc o pe 
N o h ar m t o t he 
p atie nt  
K 1 5 1 8 0 1  
7/ 2 3/ 2 0 1 5  
 Brea k;  detac h me nt  
of de vice c o m p o ne nt  
De vice detac h es fr o m t h e 
e n d osc o pe  
N o h ar m t o t he 
p atie nt  
Fi g ur e 4 . H airli k e pr oj e cti o ns ar e k n o w n f ail ur e p oi nts f or t h e Ar c E n d o c uff a n d h a v e r e s ult e d i n s e vr al d e vi c e 
br e a k a g e s d uri n g us e i n h u m a n p ati e nts.

3 2  
 
We ha ve ta ke n t his M U A D E brea ka g e data i nt o acc o u nt d uri n g t he desi g n a n d de vel o p me nt of t he 
N u Vie w de vice b y creati n g a ris k c o ntr ol t hat e ns ures re d u n da n c y t hr o u g h t he desi g n of t he 
pr ojecti o ns t he msel ves. T his ris k c o ntr ol is a n a d de d safet y l o o p (see n i n t he pict ure bel o w) 
c o n necti n g eac h hairli ke pr ojecti o n s o t hat eac h i n di vi d ual hair is n o l o n ger a ble t o detac h t hr o u g h 
a si n gle brea ka ge. I nstea d, n o w t here n ee ds t o be at least t w o brea ka g es f or a n y o ne pr oject t o 
brea k off fr o m t he de vice a n d i n s o me cases t w o brea ka g es will still n ot be s ufficie nt t o disl o d ge 
a pr ojecti o n. Si milar l y, a n ot her ris k c o ntr ol was t o desi g n o ut t he t hi n pi n-j oi nt fail ure z o ne w hic h 
we belie ve c o ntri b ute d t o se veral of t he brea ka g es of t he Arc E n d oc uff de vice a n d i nstea d us a 
m ore r o b ust a n d lar g er j oi nt of m ol de d fle xi ble material.     
We h a ve als o c o n d u cte d verificati o n tests relate d t o t he f orces re q uire d t o brea k t hese ar m-li ke 
pr ojecti o ns t o gai n c o nfi de nce i n t he de vice’s r o b ust ness. T he f oll o wi n g gi ve e xa m ples of h o w 
str o n g t hese ar m-li ke pr ojecti o ns are a n d t he n we c o m pare t his stre n gt h t o a n ot her F D A a p pr o ve d 
de vice t o gai n c o nfi de n ce t hat t h e N u Vi e w d e vice is s ufficie nt at  resisti n g t his t y pe of de vi ce 
brea ka g e.  
a.  
Stre n gt h of Vis u al E n h a nce me nt we b att ac h me nt:  
W e ha v e c h aracterize d  t he f orce re q uire d  t o  detac h t he  N u Vi e w  ar m-li ke pr ojecti o ns  
(called t he  Vis ual E n ha n ce me nt w e b ). T h e detac h me nt f orce was meas ure d b y pr o p erl y 
affi xi n g t he N u Vie w de vice t o a s mall cla m p m o u nte d t o t he b ott o m of a f orce ga u g e  a n d 
gra b bi n g i n di vi d ual we b pr ojecti o ns usi n g a n ot her cla m p attac he d t o t he le ver ar m of t he  
cali brate d f orce ga u ge. T he test set u p f or t his e x peri me nt ca n be s ee n i n t he fi g ure bel o w.   
T he safet y l o o p o n t he N u Vie w de vice were c ut t o all o w f or t he meas ure me nt of t he 
i n di vi d ual we b detac h me nt f orces .  T h e t o p cla m p was o pe ne d a n d t he first pr ojecti o n was 
i nserte d a n d t he cla m p w as s h ut. T he le ver was l o were d a n d t he N u Vi e w d e vice itself was 
attac he d t o t he m o u nte d cla m p o n t he b ott o m of t he f orce ga u g e. T he f orce o n t he f orce 
ga u ge was set t o pea k te nsi o n a n d zer oe d. T he cla m p was sl o wl y p ulle d u p war ds u ntil t he 
Fi g ur e 5 . Ris k c o ntr ol f e at ur e s i m pl e m e nt e d i n t h e N u Vi e w 
d e vi c e b as e d o n k n o w n f ail ur e s of si mil ar t y p e d e vi c e s as 
r e p ort e d i n t h e F D A's M A U D E d at a b as e. 

3 3  
pr ojecti o n beca me f ull y detac he d. T h at detac h me nt f orce was rec or d e d a n d t he e ntire test 
set u p was re peate d f or all ei g ht N u Vie w pr ojecti o ns. T hr o u g h t hese tests it was f o u n d t hat 
a n a ver a ge detac h me nt f orce of 8. 3 N  a n d mi ni m u m detac h me nt f orce of 6. 6 N   was 
re q uire d t o f ull y detac h t he vis ual e n ha nce me nt w e bs.  
T his detac h me nt  f orce gr eatl y e xcee ds t he e x pecte d f orces o n t he N u Vie w w he n de pl o ye d 
i n t he patie nt, gi vi n g c o nfi de nce t hat t he de vice will n ot u ni nte nti o nall y l ose a n y we b  
pr ojecti o ns d uri n g t he p r oce d ure. A d diti o nall y, 5 of t he pr ojecti o ns are e q ui p pe d wit h a 
safet y l o o p, i ncreasi n g t he f orce nee de d t o f ull y detac h t h ose secti o ns d uri n g a pr oce d ure. 
N o de vice fail ur es or br ea ka g es were o bser ve d i n t hese e x peri me nts. D uri n g a n act ual 
pr oce d ur e, w e d o n ot e x p ect t he w e b be d p orti o ns of t he vis ual e n h a nce m e nt we b  t o bec o m e  
de tac he d fr o m eac h ot her. T his data gi v es c o nfi de nce t hat t h e e n d os c o pe attac h me nt press 
fitti n g is m ore t ha n s ufficie ntl y r o b ust. 
T a bl e 8 . S u m m ar y of t h e f or c es r e q uir e d t o d et a c h t h e N u Vi e w Vis u al E n h a n c e m e nt w e b 
De vice  
A ver a ge F orce [ N]  Mi n F orce [ N]  M a x F orce [ N]  
1  
8. 6  
6. 6  
1 1. 0  
2  
8. 0  
7. 6  
8. 4  
3  
8. 8  
8. 4  
9. 0  
4  
7. 8  
7. 4  
8. 0  
Over all aver a g e:  
8. 3  
6. 6  
8. 0  
b.
C o m p ari n g Vis u al E n h a nce me nt we b det ac h me nt f orces t o a n F D A a p pr ove d device:
We ha v e c o m pare d t he f orce re q uire d t o det ac h t he Vis ual E n h a nce m e nt We b fr o m t he
N u Vie w  t o a n F D A a p pr o ve d distal e n d osc o pe attac h me nt de vice si milar t o t he N u Vie w,
calle d t he Arc E n d oc uff. T his is t o e ns ure t hat t he Vis ual E n ha nce me nt we b  is at least as
safe fr o m det ac h me nt e v e nts as t he o nes prese nt o n t he  Arc E n d oc uff. T he detac h me nt
f orce was meas ure d b y attac hi n g t he Arc E n d oc uff t o a cla m p a n d p ulli n g t he pr ojecti o ns
off i n di vi d uall y usi n g a cali brate d f orce ga u g e si milar t o h o w t he N u Vie w detac h me nt
f orces were c haracterize d. T hr o u g h t hese tests, it was f o u n d t hat a n a vera ge detac h me nt
Fi g ur e 6 : E x p eri m e nt al s et u p f or t h e r e m o v al of t h e N u Vi e w Vis u al 
E n h a n c e m e nt w e b  

3 4  
 
f orce of 8. 5 N a n d mi ni m u m f orce of 6. 2 0 N  is re q uire d t o f ull y detac h t h e Arc E n d oc uff 
fr o m t he e n d osc o p e. A s u m mar y of t he f orces re q uire d t o re m o ve t h e Arc E n d oc uff fr o m 
t he e n d osc o pe ca n be s ee n i n Ta ble I X. 
 
T a bl e 9 . S u m m ar y of t h e f or c es r e q uir e d t o d et a c h t h e Ar c E n d o c uff Vis u al E n h a n c e m e nt w e b  
De vice  
A ver a ge F orce [ N]  Mi n F orce [ N]  M a x F orce [ N]  
1  
7. 8  
6. 2  
9. 0  
2  
8. 9  
7. 4  
1 1. 0  
3  
8. 4  
7. 2  
1 1. 0  
4  
8. 9  
7. 8  
1 1. 4  
5  
8. 7  
7. 4  
1 1. 0  
Over all aver a g e:  
8. 5  
6. 2  
1 1. 0  
 
E ac h of t h e ar m li ke pr ojecti o ns t hat ma ke u p t h e N u Vie w’s e n ha n ce me nt we b a p pear t o be as 
r o b ust as eac h of t he ar m-li ke pr ojecti o ns of t h e F D A a p pr o ve d c o m paris o n de vice. T he N u Vi e w 
has als o i ncl u de d a saf et y l o o p t hat a d ds re d u n da nce i nt o t hese ar m -li ke pr ojecti o ns w hic h mea ns 
t hat n o si n gle fail ure ca n ca use t h e pr ojecti o n t o tear off. T he F D A c o m paris o n de vice d o es n ot 
ha ve t his re d u n da n c y a n d yet is still c o nsi dere d safe.  
Ris k S u m m ary: B ase d o n o ur revie w of t he M A U D E d at a b ase f or device bre a k a ges a n d f ail ures 
of si mil ar ty pe device t o t he N u Vie w a n d o ur pr o p ose d ris k c o ntr ols t o miti g ate t hese k n o w n 
bre a k a ges, as well as o ur verific ati o n testi n g t o e ns ure t he N u Vie w’s r o b ust ness, we h ave 
deter mi ne d t h at t he ris ks ass oci ate d wit h device f ail ures a n d bre a k a ges are c urre ntly acce pt a ble 
a n d d o n ot p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.   
 
 
Bl oc ki n g irri g ati o n/ ill u mi n ati o n ris k miti g ati o n s: 
Wit h a n y distal e n d osc o pe attac h me nt t y pe d e v ice t here is a ris k of bl oc ki n g f u ncti o nalit y of t he 
e n d osc o pe if t he de vice is p o orl y desi g ne d. F or i nsta nce, it w o ul d be eas y t o c o ver t he fr o nt face 
of t he e n d osc o pe a n d bl oc k t he irri gati o n or s ucti o n c ha n nel if t he de vice was desi g ne d i n s uc h a 
wa y t h at its mec ha nical press fitti n g c o v ere d t he fr o nt s urface of t he e n d osc o pe or h a d s o me ot her 
feat ur e w hic h bl oc ke d t he s ucti o n or irri gati o n c ha n nel. We ha ve ta ke n t his ris k i nt o acc o u nt d uri n g 
t he desi g n of t he N u Vie w a n d t he f oll o wi n g are ris k c o ntr ols w hic h will pre ve nt o ur d e vice fr o m 
bl oc ki n g f u ncti o nalit y of t he e n d osc o pe: 
1.  T he press fitti n g attac h me nt feat ure w as desi g n s uc h t hat it will o nl y c o me i nt o c o ntact 
wit h t he si de pr ofile of t he e n d osc o pe a n d will sta y sec urel y i n place wit h o ut c o veri n g t he 
fr o nt face of t he e n d os c o pe w here t he s u cti o n, i ns ufflati o n a n d irri g ati o n c ha n nels are 
l ocate d. We h a ve c o nfir me d t hat s ucti o n, i ns ufflati o n a n d irri gati o n w or k n or mall y w hile 
t he N u Vie w is attac h e d t o t he e n d osc o pe.   
2.  T he e n d ca p d esi g n offs ets t he mirr or  fr o m t he fr o nt face of t he e n d osc o pe b y > 5 m m, 
lea vi n g s ufficie nt s pace f or s ucti o n, i ns ufflati o n, a n d irri gati o n t o e nter t he s ur gical fiel d. 
F urt her, a mi ni mal li p is desi g ne d i nt o t he e n dca p t hat e xte n ds n o m ore t ha n 1 m m i nt o t he 
fr o nt face of t he e n d osc o pe, lea vi n g t he o bjecti v e le ns, ill u mi nati o n, w or ki n g c ha n nels, 
a u xiliar y water p ort, a n d le ns clea ni n g p ort u n o bstr ucte d. We ha ve c o nfir m e d t hat s ucti o n, 
i ns ufflati o n a n d irri gati o n w or k n or mall y w hile t h e N u Vie w is attac he d t o t he e n d osc o pe.  
3.  We h a ve i nc or p orat e d a 1. 7 5 m m d rai n a ge h ol e i nt o t he de vice d esi g n  l ocate d o n t h e 
str uct ural bac k b o ne of t h e N u Vie w t o e n a ble fl ui d drai ni n g. I n a d diti o n, t he s pace o p p osite 

3 5  
 
t he N u Vie w mirr or is left f ull y o pe n as s h o w n i n Fi g ure 1  pr o m oti n g f urt her drai na ge.  
Ris k S u m m ary: We h ave deter mi ne d t h at t he ris ks ass oci ate d wit h irri g ati o n/s ucti o n h ave bee n 
miti g ate d t o a n acce pt a ble level t hr o u g h t he i m ple me nte d ris k c o ntr ols  a n d as s uc h d oes n ot 
p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.  
 
 
Tiss ue tr a u m a r is k miti g ati o n s: 
Tiss ue tra u ma is i n here nt t o all e n d osc o pic pr o ce d ures. S pecific t o t he N u Vie w de vice , t he m ost 
li kel y ris ks of tiss ue tra u ma are d uri n g i nserti o n a n d re m o val of t he e n d osc o pe. We ha v e ta ke n t his 
ris k i nt o acc o u nt w he n desi g ni n g t he N u Vie w de vice a n d ha v e a d de d ris k c o ntr ol feat ures t o 
mi ni mize t he li keli h o o d of t his ris k . T he f oll o wi n g are ris k c o ntr ol meas ures were a d de d t o re d u ce 
t he ris k of tra u ma t o tiss ue t o a n acce pta ble l e vel: 
a. We ha ve desi g ne d t he N u Vie w usi n g a r o u n de d bi oc o m pati ble material t hat is e q ual t o or 
l o wer d ur o meter t ha n t h e fr o nt face of t he m ost e n d osc o pes  a n d t his s h o ul d re d uce  t he 
p ote ntial f or tra u ma t o t h e patie nt tiss ue  
b.  We ha ve i ncl u d e d a n atra u matic i nserti o n ti p  t hat is desi g ne d f or eas y i nserti o n a n d is ma de 
fr o m a s m o ot h, n o n-a brasi ve material t o re d uce f orces place d o n tiss ue d uri n g i nserti o n 
a n d na vi gati o n.  
c. We h a ve  r o u n de d  all  e x p ose d e d g es d uri n g i n acc or da n ce  wit h H E 7 5  h u ma n fact ors  
sta n dar d t o facilitate less tra u ma a n d gi ve c o nfi de nce t hat t he de vice is atra u matic o n 
i nserti o n a n d na vi gati o n. 
d.  We ha ve als o teste d t he N u Vie w i n a p orci ne c ol o n m o del, w here we i nte nti o nall y i nserte d 
a n d re m o ve d 2 of t he  de vices 5 x ti mes eac h  a n d t he n perf or me d a vis ual i ns pecti o n a n d a 
s u b mersi o n test t o i ns pect t he c ol o n f or a n y s ustai ne d tra u m a or perf oratio n. T here w as n o 
o bser va ble tiss ue da m a ge i n a n y of t hese e x p eri me nts.    
e. We ha ve acc o u nte d f or ma xi m u m i nserti o n wi dt h i n acc or da nce wit h t he i nter nati o nal 
e n d osc o pe  sta n d ar d  I S O  8 6 0 0  f or  ma xi mal  all o wa ble  i nserti o n  wi dt h.  Si milarl y,  t he  
ma xi m u m ri gi d wi d t h of t he e n d osc o p e a n d t he N u Vie w as meas ure d w hile t he N u Vie w is 
attac he d is 1 6 m m , w hic h is less t ha n ot her a p pr o ve d e n d osc o pes c urre ntl y o n t he mar ket 
w hic h are c o nsi der e d saf e t o i nsert i nt o t he patie nt. 
Ris k S u m m ary: We h ave deter mi ne d t h at w hile tiss ue tr a u m a is a n i n here nt ris k t o all dist al 
e n d osc o pe att ac h me nt ty pe devices s uc h as t he N u Vie w, t his ris k h as bee n miti g ate d t o a n 
acce pt a ble l evel t hr o u g h t he i m ple me nte d ris k c o ntr ols a n d as s uc h d oes n ot p ose seri o us ris k 
t o t he he alt h, or welf are of t he s u bject.  
 
4. 2  J ustific ati o n  f or I n vesti g ati o n 
T he g oal of t his earl y feasi bilit y st u d y is  t o de m o nstrate  t h at t he pa pilla ca n be vis ualize d usi n g a 
f or war d faci n g gastr osc o pe e q ui p pe d wit h t he N u Vie w, e na bli n g F A P patie nts t o u n der g o t heir 
yearl y r o uti ne e n d os c o pi c e x a m wit h o ut t he us e of a d u o de n os c o pe. We h y p ot hesize t hat t he 
mi ni mall y i n vasi ve e n d osc o pic pr oce d ure ma y offer t he f oll o wi n g be n efits: ( 1) re d uce d i nfecti o n 
rates d ue t o t he eli mi nati o n of t he n ee d f or a d u o d e n osc o pe, ( 2) s h orter pr o ce d ure ti me i ncl u di n g 
s h orter ge neral a nest h esia ti me d ue t o n ot nee di n g t o s witc h sc o pes mi d pr oce d ure a n d re d uci n g 
t he t otal n u m ber of sc o pes use d i n t he pr oce d ure, a n d ( 3) p ote ntiall y less tra u ma t o patie nt tiss ue 
d ue t o t he atra u matic feat ures of t he N u Vie w a n d d ue t o o nl y nee di n g t o i nsert a n d re m o ve o ne 
e n d osc o pe c o m par e d t o t w o differe nt i nserti o ns wit h t w o differe nt sc o pes.  T his  earl y feasi bilit y 

3 6  
st u d y will f oc us o n t he a d va nta ges of t he n e w tec h n ol o g y t o t he patie nt. A d va nta g es t o t he 
healt hcar e s y ste m will be e xa mi ne d d uri n g f ut ure st u dies. 
4. 3  Descri pti o n  of P atie nt  P o p ul ati o n 
T he patie nt p o p ulati o n f or t his st u d y are fa milial a de n o mat o us p ol y p osis ( F A P)  patie nts. F A P is  
ca use d b y pat h o ge nic ger mli ne varia nts i n t he A P C t u m or -s u p press or ge ne a n d is c onsi dere d a 
here ditar y ca n cer s y n dr o me. I n di vi d uals wit h F A P de vel o p h u n dre ds t o t h o usa n ds of c ol orectal 
a de n o mas, w hic h us uall y arise d uri n g a d olesce nce or earl y a d ult h o o d. O nce t he dia g n osis of F A P 
is ma de, m ost of t he atte nti o n te n ds t o f oc us o n ma na ge me nt of p ol y ps wit hi n t he c ol o n a n d u p per 
GI tract . Data fr o m hist orical F A P c o h orts esti mate d t he lifeti me ris k of i ntesti nal ca ncer t o be 
9 0 % t o 1 0 0 % f or affecte d i n di vi d uals  a n d a d va nces i n earl y detecti o n a n d pr o p h ylactic s ur ger y are 
c urre ntl y t he d efi niti ve t hera p y f or pre v e nti n g ca n cer f or mati o n  i n F A P patie nts . 
D u o de nal a n d a m p ullar y ca ncers are a lea di n g ca use of ca ncer d eat h  f or i n di vi d uals wit h F A P6. 
T he c u m ulati ve ris k of u p per GI ca n cers is c orrelate d wit h t he n u m ber, size, a n d hist ol o g y of 
d u o de nal p ol y ps ( assess e d b y S pi gel ma n et al 7 sta ges 0– I V). Ma n a ge m e nt g ui deli nes f or F A P 
iss ue d b y gastr oe nter ol o g y a n d s ur gical pr ofessi o nal s ocieties stress t he i m p orta nce of lifel o n g 
caref ul s ur veilla nce of t h e st o mac h, d u o de n u m, a n d pa pilla 8, 9, 1 0, 1 1
I n t his earl y f easi bilit y st u d y 3 a d ult s u bjects, 1 8 t o 7 0 years of a g e, will be st u die d. S u bjects will  
be recr uite d fr o m t he Gastr oe nter ol o g y cli nic at V a n der bilt U ni versit y  Me di cal  Ce nter  a n d  m ust 
q ualif y e n d osc o pic e xa mi nati o n of t he pa pilla.  Me n  a n d w o me n  of   a n y et h nicit y, race  or 
s oci oec o n o mic stat us wit h F A P w h o meet i ncl usi o n criteria will be offere d  e nr oll me nt i nt o t he 
st u d y. S u bjects  will  be scree n e d t o e ns ure t hat t h e y d o n ot ha ve a n y u n d erl yi n g c o m or bi dities or 
ot her c o nsi der ati o ns t hat w o ul d precl u de t h e us e of t h e i n vesti gati o nal de vi ce.  
6V ase n, H. F., ... & Wij ne n, J. ( 2 0 0 8). G ui deli nes f or t he cli nic al m a n a ge me nt of f a mili al a de n o m at o us p oly p osis 
( F A P). G ut, 5 7( 5), 7 0 4-7 1 3.  
7Gr oves, C. J., … & P hilli ps, R. K. S. ( 2 0 0 2). D u o de n al c a ncer i n p atie nts wit h f a mili al a de n o m at o us p oly p osis ( F A P): 
res ults of a 1 0 ye ar pr os pective st u dy. G ut, 5 0( 5), 6 3 6-6 4 1.  
8Y a n g, J., ... & S a m a d der, N. J. ( 2 0 2 0). A meric a n S ociety f or G astr oi ntesti n al E n d osc o py g ui deli ne o n t he r ole of 
e n d osc o py i n f a mili al a de n o m at o us p oly p osis sy n dr o mes. G astr oi ntesti n al e n d osc o py, 9 1( 5), 9 6 3 -9 8 2.  
9Sy n g al,  S.,  … 
&  B urt,  R.  W.  ( 2 0 1 5).  A C G  cli nic al  g ui deli ne:  ge netic  testi n g  a n d  m a n a ge me nt  of  here dit ary  
g astr oi ntesti n al c a ncer sy n dr o mes. T he A meric a n j o ur n al of g astr oe nter ol o gy, 1 1 0( 2), 2 2 3.  
1 0M o n a h a n, K. J., ... & Hill, J. ( 2 0 2 0). G ui deli nes f or t he m a n a ge me nt of here dit ary c ol orect al c a ncer fr o m t he Britis h 
S ociety of G astr oe nter ol o gy ( B S G)/ Ass oci ati o n of C ol o pr oct ol o gy of Gre at Brit ai n a n d Irel a n d ( A C P G BI)/ U nite d 
Ki n g d o m C a ncer ge netics gr o u p ( U K C G G). G ut, 6 9( 3), 4 1 1 -4 4 4.  
1 1v a n Leer d a m, M. E., ... & Ric ci ar diell o, L. ( 2 0 1 9). E n d osc o pic m a n a ge me nt of p oly p osis sy n dr o mes: E ur o pe a n 
S ociety of G astr oi ntesti n al E n d osc o py ( E S G E) g ui deli ne. E n d osc o py, 5 1( 0 9), 8 7 7 -8 9

3 7  
5.
D E S C RI P TI O N  O F  T H E P R O C E D U R E
A n o ver vie w of t he pr oce d ure c a n be see n i n bel o w.
Fi g ur e 7 . St u d y o v er vi e w s h o wi n g t h e pr o p os e d fl o w of t h e e x p eri m e nt. N ot e t h at st e p 6 is t h e o nl y 
i n v e sti g ati o n al st e p wit hi n t his st u d y. All ot h er st e ps ( wit h t h e e x cl usi o n of t h e p ost-o p s ur g e o n  N A S A i n d e x 
/ q u e sti o n n air e) ar e c urr e ntl y t h e st a n d ar d of c ar e f or F A P p ati e nts u n d er g oi n g r o ut i n e e n d os c o pi c 
  

3 8  
As detaile d bel o w a n d i n  Fi g ure 6 , t he c o m p o ne nts in Ta ble I are use d p erf or m t he yearl y r o uti ne 
e n d osc o pic e xa mi nati o n of F A P patie nts.  T he o nl y i n vesti gati o nal ste p is w h e n t he N u Vie w de vice 
is attac he d o n t he e n d osc o pe a n d use d t o vis ualize t he pa pilla. T h ere is n o t h era p y deli vere d d uri n g 
t his pr oce d ure a n d t he o nl y pri mar y e n d p oi nt i n t his feasi bilit y st u d y is t o s uccessf ull y vis ualize 
t he pa pilla usi n g t he N u Vie w.  
5. 1  S T E P 1: O btai n Patie nt C o nse nt.  T he p ot e ntial partici pa nt will be pr o vi de d wit h a c o p y of t he 
c o nse nt f or m t o r ea d a n d will be pr o vi de d wit h a n o p p ort u nit y t o as k q u esti o ns. O nce t he 
st u d y partici pa nt’s q uesti o ns ha ve bee n a ns w ere d a n d pri or t o perf or mi n g a n y st u d y-relate d 
pr oce d ur e, a n I R B -a p pr o ve d c o ns e nt f or m will be si g ne d a n d date d b y t h e st u d y partici pa nt 
a n d b y t he pers o n o btai ni n g i nf or me d c o nse nt. A c o p y of t he si g ne d c o nse nt f or m will be 
pr o vi de d t o t he s u bject a n d t he i nf or me d c o nse nt pr ocess will be d oc u m e nte d i n t he st u d y 
partici pa nt’s me dical rec or d.  
5. 2  S T E P 2:  Re vie w I ncl usi o n / E xcl usi o n Criteria. Pri or t o t he st u d y, w he n a p ote ntial ca n di date 
is i de ntifie d, a re vie w of t he i ncl usi o n/e xcl usi o n criteria will be perf or m e d. Na mel y, t he 
patie nt m ust be: (1) bet w ee n t he a g es of 1 8 t o 7 0 years ol d, a n d (2) m ust be a ble t o pr o vi de 
writ te n i nf or me d c o nse nt. Si milarl y, t he ca n di d ate m ust n ot be: (1) c urre ntl y pre g na nt, a n d  
( 2) ca n n ot b e c urre ntl y dia g n ose d or bei n g treate d f or ca n cer.
5. 3  S T E P 3:  Re vie w  Me dical Hist or y. I n li ne wit h sta n dar d cli nical practice, t he patie nt’s me dical 
hist or y will be r e vie we d bef ore t he pr oce d ure t o e ns ure t he ca n di d ate d o es n ot ha ve a n y ite ms 
t hat w o ul d precl u de t he m fr o m bei n g a g o o d ca n di date f or t he pr oce d ure.  
5. 4  S T E P 4:  R o ut i ne Pre g na nc y Test (fe male p artici p a nts). A n y i de ntifie d ca n di date t hat is fe male 
will ha ve a r o uti ne pre g na nc y test pri or t o t he pr oce d ure as part of t he i ncl usi o n/e xcl usi o n criteria. 
T h ose partici pa nts w h o are c o nfir me d t o be pre g na nt will be e xcl u d e d fr o m t he st u d y.  
5. 5  S T E P   5: Gast r osc o pe e n d osc o pic assess me nt. Usi n g a sta n dar d gastr osc o pe, t he Ol y m p us 
GI F -H 1 9 0 , t he s ur ge o n will i ntr o d uce t he sc o p e i nt o t he p atie nt t o ass ess t he es o p h a g us, 
st o mac h, a n d d u o de n u m f or p ol y ps. T his will be perf or me d p er t he sta n d ar d of care wit h o ut 
de viati o n fr o m t he c urre nt cli nical practice d uri n g t he yearl y r o uti ne e n d osc o pic e xa mi nati o ns 
f or F A P patie nts.   
5. 6  S T E P 6: E n d osc o pic vis ualizati o n of t he pa pilla usi n g t he N u Vie w (i nvesti g ati o n al ste p). 
O nce t he s ur ge o n has c o m plete d t he i nitial assess me nt usi n g a gastr osc o pe t he N u Vie w de vice 
will  be  attac he d  t o  t he  gastr osc o pe  a n d  i ntr o d uce d  i nt o  t he  patie nt.  T h e  de vice  will  be  
na vi gate d t o t he d u o de n u m a n d t he pa pilla will be vis ualize d. E xact se q ue ntial pr ot oc ol f or 
t his ste p is as f oll o ws:   
a. T he N u Vie w’s sterile pac ka gi n g will be i ns pecte d a n d c o nfir me d i ntact.
b. T he N u Vie w’s pac k a gi n g  will be o pe ne d.
c. T he N u Vi e w will b e att ac he d t o t he g astr osc o pe a n d  t he fitti n g a n d attac h me nt will be
c o nfir me d t o be sec ur e.
d. T he gastr osc o pe e q ui p pe d wit h t he N u Vie w will be i nserte d i nt o t he patie nt  i n t he sta n dar d
e n d osc o pic f as hi o n.
e. T he gastr osc o pe will be na vi gate d t o t he d u o de n u m a n d t he pa pilla will be vis ualize d usi n g
t he N u Vie w.
f. T he gastr osc o p e a n d de vi ce will be re m o v e d fr o m t he patie nt.

3 9  
T his is t he i n vesti gati o nal ste p of t he pr ot oc ol. All s u bse q ue nt ste ps will be perf or me d p er t he 
stan dar d of car e as t he y are us uall y perf or me d f or r o uti ne e n d o sc o pic F A P e xa mi nati o ns.  
5. 7  S T E P 7: C o nfir mati o n usi n g a sta n dar d d u o de n os c o pe .  T he s ur ge o n will t he n c o nfir m pa pilla 
vis ualizati o n usi n g a sec o n dar y met h o d w hic h is cli nicall y acce pte d. T his will be ac hie ve d b y 
i nserti n g a sta n dar d d u o de n osc o pe, t h e Ol y m p us TJ F-Q 1 8 0 V, t o vis ualize t he pa pilla. T his 
will e ns ure t hat a n yt hi n g n ot vis ualize d wit h t he N u Vie w will be see n usi n g a sta n dar d 
cli nicall y acce pt e d met h o d. F urt her a n yt hi n g t hat was vis ualize d b y t he N u Vie w will a gai n be 
vis ualize d usi n g a sec o n d cli nicall y-acce pt e d sta n dar d  met h o d. T he i nserti o n a n d assess me nt 
wit h t he D u o de n osc o pe will be perf or me d per t h e sta n dar d of care , usi n g t he sta n dar d pr ot oc ol 
f or F A P patie nts d uri n g r o uti ne yearl y e n d osc o pi c e xa mi nati o ns. T he s ur ge o n will i nsert a 
d u o de n osc o pe i nt o t he patie nt a n d na vi gat e t o t he d u o de n u m. T he  p a pilla will be i ns pecte d t o 
c o nfir m w hat was vis ualiz e d usi n g t he N u Vie w de vice. T his is a pr otecti o n i n li ne wit h w hat 
is  o utli ne d  i n  2 1  C F R  8 1 2,  w hic h  states t hat  a n y  dia g n ostic  N S R  de vice  m ust ha ve  a  
c o nfir mati o n of di a g n osis usi n g a sec o n d cli nicall y acce pte d met h o d. O n ce t he pa pilla h as 
bee n vis ualize d usi n g t he d u o de n osc o pe, t he sc o pe will be re m o ve d fr o m t he patie nt i n t he 
sta n dar d cli nical met h o d.  
5. 8  S T E P 8:  Re vie w of a d verse e v e nts.  I n li ne wit h sta n dar d cli nical practice, patie nts will be 
cl osel y  m o nit ore d  d uri n g  t he  pr oce d ure  a n d  i n  a  rec o ver y -r o o m s etti n g  f oll o wi n g  t he  
pr oce d ur e. All a vaila ble cli nical data, i ncl u di n g e xa m fi n di n gs, a n d cli nical i m pressi o ns, will 
be m o nit ore d. T he i n vesti gat or will e val uate a n y c h a n ges i n p h ysical stat us a n d will deter mi ne 
if t he c ha n ge is cli nicall y i m p orta nt a n d differe nt fr o m w hat is a ntici pate d i n t he c o urse of 
treat me nt. Si milarl y, t he i n vesti gat or a n d s u b-i n vesti gat ors will assess o n a r o uti ne basis if 
a n y a d vers e e ve nts occ ur d uri n g t he st u d y at a n y p oi nt. All a d verse e ve nts/c o m plicati o ns t hat 
occ ur d uri n g t he st u d y w het her de vice relate d or n ot will be re p orte d a n d rec or de d.  
5. 9  S T E P  9: P o st-e n d osc o p y s ur ge o n N A S A i n de x / q uesti o n naire. F oll o wi n g t he pr o ce d ure, a 
s h ort N A S A tas k l oa d i n de x / q u esti o n naire will be gi ve n t o t he s ur ge o n t o e x pl ore vari o us 
ite ms of i nterest relate d t o t he usea bilit y of t he de vice s uc h as me ntal de ma n d, p h ysical de ma n d, 
eff ort, fr ustrati o n, etc. ( A p pe n di x D) 
6. M O NI T O RI N G  P R O C E D U R E S
As   t he Pri nci pal   I n v esti gat or ( PI)  of t his earl y  feasi bilit y  st u d y, Dr.  Keit h  O bstei n  will  be 
res p o nsi ble f or o vers eei n g t he safet y of t his trial o n a dail y basis. Cli nical data will be re vie we d 
dail y  f or a d v erse  e v e nts. I n  a d diti o n, Dr.  O bstei n  is a vaila ble t o  t he  s u b- i n vesti gat ors, 
researc h staff, a n d be dsi de n urses, w h o will be m o nit ori n g partici pa nts f or a d v erse e ve nts. All 
u na ntici pate d a d verse de vice effects will be pr o m ptl y e val uate d a n d  re p orte d as per pr ot oc ol i n 
Secti o n 3. 6. 1. 2 . Dr. O bstei n  ma y pa use t he t rial t o i n vesti gate p ossi ble safet y relate d iss ues a n d/ or 
s u b mit c ha n ges t o t he st u d y desi g n t o a d dress a n y safet y-relate d c o n cer ns  a n d ma y   disc o nti n ue 
t he trial  s h o ul d ris ks t o partici pa nts   be c o nsi dere d  u nacce pta ble.  
S h o ul d it be disc o vere d t hat a s u b -i nvesti gat or is n ot i n c o m plia nce wit h t he si g ne d  a gree me nt, t h e 
a p pr o ve d i n vesti gati o nal pla n, or a n y I R B re q uire me nts f or t he   c o n d ucti o n  of t his  st u d y, Dr.  
O bstei n  will  pr o m ptl y sec ure c o m plia nce  or t he s u b- i n vesti gat or will  be re m o ve d fr o m t he st u d y. 

4 0  
6. 1  Writ te n M o nit ori n g Pr oce d ures 
Dr. O bstei n  will  perf or m  re vie ws a n d/ or acc or di n g t o t he f oll o wi n g se q ue ntial sc he d ule: 
-
After  t he first patie nt  u n der g oes t he researc h pr ot o c ol.
-
At  a n y  p oi nt i n w hic h   a n a d verse e v e nt is  e nc o u ntere d  a n d/ or at a n y ti me w here  t he
ris k/ be nefit of t he researc h c ha n ges.
-
At  a n y  p oi nt at w hic h   a  c o m plai nt  of  a researc h partici pa nt  is recei ve d t hat ca n n ot be
res ol ve d b y t he pri nci pal i n vesti gat or ( PI) a n d/ or researc h c o or di nat or ( R C).
Eac h  re vie w w ill res ult i n a writte n  re p ort s u m marizi n g t he m o nit ors fi n di n gs. 

4 1  
 
7.  L A B E LI N G  
 
 
 
Va n d er bilt U ni v ersit y Me dical Ce nter  
Di g esti v e Diseases Ce nter  
1 3 0 1 Me dical Ce nter , Dr s uite 1 6 6 0  
Nas h ville,  T N 3 7 2 3 2  
P h o n e:  ( T B D) X X X -X X X X  
C o nte nts:  
O ne N u Vie w d e vice  
C A U TI O N:  I n vesti g ati o n al De vice.  Li mite d  b y  Fe der al  ( or U nite d  St ates)  
l a w t o i n vesti g ati o n al use. 
 
Ca uti o nar y State me nt:  De vice o nl y t o be use d u n der t he directi o n of t he 
i n vesti gat ors of Va n der bilt I R B a p pr o val n u m ber T B D # . 

4 2  
 
8.  C O N S E N T  M A T E RI A L S  
I nf or me d c o nse nt will be o btai ne d pri or t o t he st u d y. Please see A p pe n di x E  f or i nf or me d re g ar di n g 
i nf or me d c o nse nt d oc u m e ntati o n.  

4 3  
 
9.  
I R B I N F O R M A TI O N 
T he st u d y will be  s u b mitte d i n sta n dar d fas hi o n via t he V U M C H u ma n Researc h Pr otecti o ns 
Pr o gra m o nli ne platf or m a n d  assi g ne d t o t he I R B Healt h Scie nces C o m mittee C hair f or assi g n me nt 
a n d re vie w.  
 
Va n der bilt H u ma n Researc h Pr otecti o n Pr o gra m 
 Healt h  Scie nces C o m mittee  
1 3 1 3 2 1 st A ve.  S.  
5 0 4 O xf or d H o use  
Nas h ville, T N 3 7 2 3 2- 4 3 1 5  

4 4  
 
1 0.  O T H E R  I N S TI T U TI O N S 
Va n der bilt U ni versit y  Me dical  Ce nt er  is t he o nl y i nstit utio n partici pati n g  i n t his earl y feasi bilit y 
st u d y. 

4 5  
 
1 1.  A D DI TI O N A L  R E C O R D S  A N D  R E P O R T S  
C o m plete a n d acc urate r ec or ds will be ke pt d uri n g t he i n vesti gati o n a n d f or a peri o d of 2  years  
after eit her t h e date  o n w hic h  t he i n vesti gati o n is ter mi nate d or c o m plete d or t he dat e  t hat rec or ds 
are  n o  l o n ger r e q uire d i n  s u p p ort  of  an  F D A  mar ket  a p plicati o n . Rec or ds  will  i ncl u de  all  
c orres p o n d e nce  r ele va nt  t o  t he  i n vesti gati o n,  I R B  a p pr o ve d  st u d y  d oc u me nts,  de vice  
acc o u nta bilit y rec or ds, s o urce a n d case re p ort f or m  d oc u m e ntati o n, t o  i n cl u de si g n e d  c o nse nt 
d oc u me ntati o n a n d  a n y a d verse e v e nt re p orts f or a n y partici pa nt.  

4 6  
1 2. M A N U F A C T U RI N G
T he  N u Vie w  c o nsists  of  t hree c o m p o ne nts  t hat  are  ma n ufact ure d  i n de pe n de ntl y  usi n g 
bi oc o m pati ble materials: t he str uct ural s u p p ort, mirr or, a n d press -fit c ollar. T hese c o m p o ne nts are 
s h o w n i n Fi g ure 7 , b el o w. T his secti o n details t he ma n ufact uri n g pla n f or eac h c o m p o ne nt, as well 
as t he asse m bl y a n d sterilizati o n pr ocesses f or t he c o m plete d N u Vie w d e vice.  
Fi g ur e 8 : T hr e e c o m p o n e nts of N u Vi e w d e vi c e. E a c h c o m p o n e nt will b e m a n uf a ct ur e d i n d e p e n d e ntl y, f ast e n e d wit h 
m e di c al -gr a d e a d h e si v e,  p a c k a g e d,  a n d st eriliz e d.  
Str uct ur al S u p p ort:  t he str uct ural s u p p ort c o m p o ne nt will be m a n ufact ure d usi n g a F or mla bs 
F or m 3 3 D pri nter ( S o mer ville, M A). T h e F or m 3 is a stere olit h o gra p h y ( S L A) 3 D pri nter, w hic h 
uses a U V laser t o c ure li q ui d material resi ns la yer - b y-la yer o n a de dicate d b uil d tra y. M ore 
i nf or mati o n  o n  t he  F or m  3  ca n  be  f o u n d  at  htt ps://f or mla bs.c o m/ 3 d -pri nters/f or m - 3/. T his 
c o m p o ne nt is 3 D pri nte d usi n g F or mla bs T o u g h 1 5 0 0 Resi n, a resilie nt material desi g ne d f or stiff 
a n d plia ble parts wit h si milar stre n gt h a n d stiff ness t o p ol y pr o p yle ne. T o u g h 1 5 0 0 Resi n is a 
me dical -gr a de, bi oc o m p ati ble material t hat is certifie d f or p er ma n e nt s ki n c o ntact. 1 After pri nti n g, 
the str uct ural s u p p ort c o m p o ne nt will be clea n e d i n 9 9 % is o pr o p yl alc o h ol usi n g t he rec o m me n d e d 
F or m Was h s etti n gs a n d t he n c ure d t o f ull stre n gt h usi n g t he rec o m me n de d F or m C ure te m perat ure 
pr ofile. F oll o wi n g t he c uri n g pr ocess, e x cess material fr o m t he 3 D  pri nti n g pr ocess (i.e., s u p p ort 
material) will be re m o ve d wit h si de -c utti n g pliers a n d t he s u p p ort l ocati o ns will be fi nis he d wit h 
sa n d pa per f or a s m o ot h, u nif or m s urface fi nis h. 
Mirr or:  T he mirr or is m a de fr o m 1 m m -t hic k mirr ore d glass (a b or osilicat e su bstrate wit h a t hi n 
1 A d diti o n i nf or mati o n o n F or mla bs T o u g h 1 5 0 0 resi n a n d its I S O 1 0 9 9 3 bi oc o m pati bilit y certificati o n ca n be f o u n d 
at htt ps://f or mla bs -me dia.f or mla bs.c o m/ datas heets/ T o u g h _ 1 5 0 0 _ T D S _ E N. p df  a n d 

4 7  
e n ha nce d al u mi n u m mirr or c oati n g). T his c o m p o ne nt will be c ust o m -ma n ufact ure d b y K ni g ht 
O ptical usi n g a scri bi n g pr ocess. U p o n deli ver y t o E n d o T heia, t he mirr or will be clea ne d usi n g 
9 9 % is o pr o p yl alc o h ol pri or t o asse m bl y. 
Press -Fit C oll ar:  t he pr ess -fit c ollar is desi g ne d t o be s oft a n d elastic i n or der t o s afel y i nteract 
wit h tiss ue d uri n g F A P, as well as t o fit ti g htl y o n t he ti p of t h e e n d os c o pe . It will be ma de fr o m a 
s oft, bi oc o m pati ble, a n d tear-r esista nce silic o ne uret ha ne elas t o mer t hat is i deal f or s ki n-c o ntact 
a n d m uc osal me m bra ne a p plicati o ns. T his s oft silic o n e uret ha ne elast o mer is k n o w n as SI L -3 0 a n d 
will be s u p plie d t o us fr o m Car b o n, I nc. It has u n der g o ne ri g or o us bi oc o m p ati bilit y/sterilit y testi n g 
w hic h ma kes it i deal f or s h ort-ter m m uc osal me m bra ne c o nt act ( u p t o 2 4 h i n d urati o n). See 
A p pe n di x B  f or a d diti o nal details relati n g t o bi oc o m pati bilit y a n d sterilit y.      
Asse m bl y:  All c o m p o ne nts will be sec ure d t o get her usi n g me dical -gra d e, bi oc o m pati ble L octite 
# 4 3 5 c ya n oacr ylate ( H e n kel C or p orati o n, R oc k y Hill, C T). 2  T he L octite c ya n oacr yl ate will be 
all o we d t o c ure f or a f ull 2 4 h o urs bef ore pr ocee di n g t o sterilizati o n. 
Steriliz ati o n:  F oll o wi n g asse m bl y, t he c o m plete d N u Vie w de vi ce will be sterilize d acc or di n g t o 
pr ot oc ols vali date d b y S T E RI S   ( M e nt or, O hi o ) a n d i ncl u de d i n A p p e n di x  B , S T E RI S Stea m 
Sterilizati o n Vali dati o n Re p ort, w hic h s pecifi es t he f oll o wi n g para m eters: 
Sterilizer T y pe:  
Pre vac u u m  
Mi ni m u m Te m perat ure:  
1 3 2 C  
Sterilizati o n  C ycle Ti me:  
Dr y p hase: 
Test Article C o nfi g urati o n:  
4 mi n utes 
3 0 mi ns 
Si n gle wra p pe d  
2 L octite # 4 3 5 is I S O 1 0 9 9 3 certifie d. M ore i nf or mati o n ca n be f o u n d at 
htt p://t ds. he n kel.c o m/t ds 5/ St u di o/ S h o w P D F/? pi d = 4 3 5 &f or mat = M T R &s u bf or mat = R E A C &la n g ua ge = E N & pla nt = W
E R C S , htt ps:// we b -
e mea. he n kel.c o m/a d hesi ves/ he n kel/ pr o d ucta p pr o vals. nsf/ 2 4e 9 8e 1 1f 0a 9f 0c 7 8 0 2 5 7 2f 3 0 0 4 8 4 9 6 5/ 0 9 0 8 d 3 8 9 0 5a 2 7 2 8e
c 1 2 5 8 3 0 7 0 0 2 9 9 d b 5/ $ FI L E/ L octite % 2 0 4 3 5, % 2 0 Bi oc o m pati bilit y, % 2 0I S O % 2 0 1 0 9 9 3, % 2 0 2 0 0 9, % 2 0 U S % 2 0 ma n ufa
ct ure d % 2 0 o nl y. p df , a n d htt ps:// d m. he n kel -da m. c o m/is/c o nte nt/ he n kel/ me dical -pr o d uct -select or-g ui de -a d hesi ves-
f or-me dical -de vice -asse m bl y   

4 8  
A p pe n di x A: M A U D E d at a re vie w f or 
de vices si mil ar t o t he N u Vie w 

4 9  
 
T his secti o n pr o vi des a r e vie w of t he M A U D E data relate d t o t he Arc E n d oc uff de vi ce. T he d ata 
prese nte d is bas e d o n all a vaila ble r e p orts bet wee n Ja n uar y 1, 2 0 0 0 t o J ul y 3 1, 2 0 2 1. T o date, 
t here ha v e bee n a t otal of 1 1 M A U D E re p orts f or t he Arc E n d o c uff as s h o w n i n Ta ble 1 0 .    
 
T a bl e 1 0 : M A U D E d at a f or t h e Ar c E n d o c uff 
M A U D E D A T A: A R C E N D O C U F F ( all a v ail a ble d at a)
 
De vice  
D ate  
Pr o ble m  
Descri pti o n  
H ar m  
K 1 5 1 8 0 1  
1 2/ 0 9/ 2 0 1 5  
 Detac h me nt of d e vice c o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
1 0/ 2 4/ 2 0 1 5  
 Detac h me nt of de vice c o m p o ne nt  
De v ice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
1 0/ 2 4/ 2 0 1 5  
 Detac h me nt of de vice c o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
7/ 2 3/ 2 0 1 5  
 Brea k; detac h me nt of de vice 
c o m p o ne nt 
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
5/ 1 3/ 2 0 1 5  
 Detac h me nt of d e vice c o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
4/ 2 9/ 2 0 1 5  
 Detac h me nt of de vice 
c o m p o ne nt; Diffic ult t o re m o ve 
De vice detac hes fr o m t he 
en d osc o pe  
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
4/ 1 7/ 2 0 1 5  
 Detac h me nt of d e vice c o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 5 1 8 0 1  
2/ 1 9/ 2 0 1 4  
 A d verse E ve nt Wit h o ut I de ntifie d 
De vice or Use Pr o ble m  
A n a d verse e ve nt t hat was 
n ot attri b ute d t o t he de vice  
N o h ar m attri b ute d t o de v ice 
K 1 5 1 8 0 1  
1 0/ 1 8/ 2 0 1 3  
 A d verse E ve nt Wit h o ut I de ntifie d 
De vice or Use Pr o ble m  
A n a d verse e ve nt t hat was 
n ot attri b ute d t o t he de vice  
N o h ar m attri b ute d t o de vice  
 
Re vie w of t he a vaila ble M A U D E data f or t he pre dicate de vice, t he Arc E n d oc uff, s h o ws t hat t he 
m ost  c o m m o nl y  re p orte d  de vice  pr o ble m  is  t hat  of  detac h me nt  fr o m  t he  e n d osc o pe.  T h ese  
detac h me nts d o n ot a p pear t o res ult i n a n y har m t o t he patie nt, as i n  all 8 u ni nte n de d detac h me nt 
e ve nts, n o patie nt was re p orte d t o ha ve bee n har me d a n d n o f oll o w u p treat me nt was rec o m me n de d 
i n a n y case.  F urt h er, n o n e of t h ese d etac h me nt e ve nts has bee n c o ntri b ute d t o mis use of t he de vice 
i n a n y of t he M A U D E d ata base r e ports.  
T he o ut p ut of t his M A U D E data has bee n i nc or p orate d i nt o t he pr o d uct de vel o p me nt pr ocess of 
t he E n d o T heia N u Vie w. F urt her, a r e vie w of t he M A U D E data bas e i n dicates t hat s ur ge o ns ca n 
use t he Arc E n d oc uff pre dicate de vice safel y, as n ot a si n gle har m of seri o us nat ure was attri b ute d 
t o t he de vice i n a n y of t he M A U D E re p orts. It t heref ore st a n ds t o reas o n t hat, d ue t o t h e si milarities 
bet wee n t he Ar c E n d oc uff a n d t he E n d o T heia N u Vie w, s ur ge o ns s h o ul d als o be a ble t o use t he 
N u Vie w safel y. We will c o nfir m t his t hr o u g h o ur Use Relate d Ris k Assess me nt pr ocess, as well 
as t hr o u g h o ur de v el o p me nt Verificati o n & Vali dati o n testi n g.   
 
M A U D E D at a f or de vices si mil ar t o t he E n d o T hei a N u Vie w  
As part of o ur ris k assess me nt, a n d i n a n eff ort t o ta ke a br oa d a p pr oac h at u n dersta n di n g t he 
p ote ntial use r elate d err ors t hat users mi g ht e x p erie nce w hile usi n g t he N u Vie w de vi ce, we ha ve 
als o re vie w e d t he M A U D E data bas e re p orts f or ot her si milar de vice s t o t h e E n d o T heia N u Vie w.  
E n d o Ai d’s E n d o Ri n gs dist al e n d osc o pe att ac h me nt device:  

5 0  
 
E n d o Ai d’s E n d o Ri n gs is a distal e n d osc o pe attac h me nt a n d is ver y si milar t o t he N u Vie w i n b ot h 
tec h n ol o g y a n d i n i nte n de d use. T he E n d o Ri n gs de vice has t he f oll o wi n g i nte n de d use, “T he 
E n d o Ri n gs is i nte n de d t o be att ac he d t o t he dist al e n d of t he e n d osc o pe t o f acilit ate e n d osc o pic 
t her a py, t o be use d f or t he f oll o wi n g: Kee pi n g t he s uit a ble de pt h of e n d osc o pe’s vie w fiel d. ”  
Beca use of t he si milarities bet wee n t he t w o de vi ces, we belie ve t hat t he M A U D E data bas e re p orts 
f or t he E n d o Ri n gs ar e hi g hl y rele va nt t o t he N u Vie w de vice a n d s h o ul d be c o nsi dere d i n o ur d esi g n 
pr ocess. All a v aila ble re p orts f or t he E n d o Ri n gs are prese nt e d i n Ta ble 1 1 .   
 
T a bl e 1 1 : M A U D E d at a f or E n d ori n gs  
M A U D E D A T A: E N D O RI N G S ( all a v ail a ble d at a)
 
De vice  
Re p ort  
Pr o ble m  
Descri pti o n  
H ar m  
K 1 3 3 3 5 9  
1 2/ 0 1/ 2 0 1 7  
Detac h me nt Of De vice 
C o m p o ne nt  
De vi ce detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 2/ 0 8/ 2 0 1 7  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 2/ 0 8/ 2 0 1 7  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 1/ 2 7/ 2 0 1 7  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
1 2/ 1 3/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 7/ 1 3/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 3/ 1 8/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 3/ 0 3/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 8/ 2 7/ 2 0 1 5  
Detac h me nt Of De vice 
C o m p o ne nt  
De vi ce detac hes fr o m t he 
e n d osc o pe 
N o h ar m t o t he p atie nt  
K 1 3 3 3 5 9  
0 8/ 1 3/ 2 0 1 5  
A d verse E ve nt Wit h o ut 
I de ntifie d De vice or Use 
Pr o ble m  
A n a d verse e ve nt t hat was 
n ot attri b ute d t o t he de vice  
N o h ar m t o t he p atie nt  
It is clear t hat t he m ost c o m m o n pr o ble m wit h t he E n d o Ri n gs is u ni nte n de d de vice detac h me nt as 
all 1 0 re p orts are i n re gar d t o t his o bser ve d pr o ble m. W hile t here was n o patie nt har m i n a n y of 
t hese re p orts, it is i m p orta nt i nf or mati o n re gar di n g li kel y a d verse e ve nts t hat we c o ul d p ote ntiall y 
see i n re g ar ds t o t he N u Vie w de vice.  We h a ve ta ke n t his i nf or mati o n i nt o acc o u nt wit hi n o ur 
desi g n a n d de vel o p me nt pr ocess a n d pla n t o i ncl u de ris k miti gati o ns relati n g t o detac h me nt s uc h 
as  t he  i ncl usi o n  of  clas pi n g  f eat ures  as  well  as  s pecific  t olera n ce  s pecs  relati n g  t he  
N u Vie w/e n d osc o p e fitti n g. E xact ris k c o ntr ols ar o u n d p ossi ble detac h me nt e ve nts are still u n der 
de vel o p me nt. A n ot her t hi n g t hat sta n ds o ut i n re g ar ds t o t h e M A U D E d ata f or t he E n d o Ri n gs is 
t hat t he de vi ce a p pears t o be relati vel y s afe t o us e as n o ne of t hes e d etac h me nt e ve nts l e d t o a n y 
patie nt/ user har m.  
U nite d St ates E n d osc o py Gr o u p’s T he U S E n d osc o py Dist al Att ac h me nt C a p device: 
A n ot her de vice w hic h is si milar t o t he N u Vie w de vice i n ter ms of tec h n ol o gical c haracteristics is 
t hat of U nite d States E n d osc o p y Gr o u p’s “T h e U S E n d osc o py Dist al Att ac h me nt C a p ” de vice. 

5 1  
 
T his de vice’s i nte n de d use is s o me w hat si milar t o t he N u Vie w de vice e x ce pt t hat it als o i ncl u des 
a n i n dicati o n f or “ gastr oi ntesti nal m uc osal resecti o n” w hic h t he N u Vie w de vice is n ot i nte n de d 
f or. Still, M A U D E re p orts f or t he U S E n d osc o p y Distal Attac h me nt Ca p are rele v a nt t o t he 
N u Vie w i n t hat t he y ar e b ot h distal e n d osc o pe attac h me nt t y pe de vices. All p u blicl y a vaila ble 
M A U D E data f or T he U S E n d osc o p y Distal Attac h me nt Ca p is prese nte d i n Ta ble 1 2 . 
 
T a bl e 1 2 : M A U D E d at a f or R e v e al Dist al Att a c h m e nt C a p 
M A U D E D A T A: R E V E A L DI S T A L A T T A C H M E N T C A P  ( all a v ail a ble d at a) 
De vice  
Re p ort  
Pr o ble m  
Descri pti o n  
H ar m  
K 1 4 0 3 1 5  
0 1/ 2 9/ 2 0 2 1  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 7/ 2 9/ 2 0 1 9  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 2/ 1 3/ 2 0 1 9  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 9/ 2 6/ 2 0 1 8  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 4/ 0 8/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 4/ 0 8/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 3/ 0 3/ 2 0 1 6  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
K 1 4 0 3 1 5  
0 9/ 1 7/ 2 0 1 5  
Detac h me nt Of De vice 
C o m p o ne nt  
De vice detac hes fr o m t he e n d osc o pe  
N o h ar m t o t he p atie nt  
T he M A U D E data f or T h e U S Distal Attac h me nt C a p de vice p oi nts t o u ni nte n de d detac h me nt as 
t he m ost c o m m o n pr o ble m f or t his de vice. Si nce t his de vice’s i ntr o d ucti o n i nt o t he mar ket place 
t here h a ve b ee n a t otal of 9 re p orts, all of w hic h rel ate t o t he u ni nte n d e d detac h me nt of t he de vice. 
N o patie nt/ user har m was see n i n a n y of t hese 9 re p orts, a gai n s u g gesti n g t hat t his de vice (li ke t he 
E n d o Ri n gs de vice) a p p ears t o be relati vel y safe f or use.     
O verall, o ur r e vie w of t h e M A U D E data b ase f or de vices si milar t o t he N u Vie w de vice s u g g est 
t hat  u ni nte nti o nal  de vice  detac h me nt  will  be  t he  m ost  pr o ba ble  pr o ble m  t hat  we  are  li kel y  
e nc o u nter. F ort u natel y, t his pr o ble m d oes n ot a p p ear t o lea d t o a seri o us le vel har m, as n o n e of t he 
re p orts s u g gest patie nt har m relate d t o t his detac h me nt iss ue. Ne vert heless, we are t a ki n g t his i nt o 
u n der a d vise me nt d uri n g t he de vel o p me nt of o ur de vice a n d pla n t o i m ple me nt ris k c o ntr ols f or 
t his k n o w n iss ue i n ot her si milar de vices.  
 
 
 

5 2  
 
 
 
 
 
 
 
 
A p pe n di x B: De vice Bi oc o m p ati bilit y & 
Sterilit y I nf or m ati o n  
 
 

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
SI L 3 0
SI L 3 0 is a s oft, bi o c o m p ati bl e, a n d t e ar -r esist a nt 
sili c o n e ur et h a n e el ast o m er t h at is i d e al f or s ki n -
c o nt a ct a p pli c ati o ns.
1

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
T e n sil e Pr o p erti es 
A S T M D 412, Die C, 5 0 0 m m/ mi n
M etri c
U S
T e nsile M o d ul us
3 M Pa
4 4 0 psi
El o n gati o n at Break
3 5 0 %
3 5 0 %
Stress at 5 0 % El o n gati o n
0. 4 M Pa
6 0 psi
Stress at 1 0 0 % El o n gati o n
0.7 M Pa
1 0 0 psi
Stress at 2 0 0 % El o n gati o n 
1. 5 M Pa
22 0 psi
Ulti mat e T e nsile Stre n gt h
3. 5 M Pa
5 0 0 psi
Ot h er M e c h a ni c al Pr o p erti es
M etri c
U S
T ear Stre n gt h, Die C ( die c ut), A S T M D 62 4
1 0 k N/ m
57 l bf/i n
C o m pressi o n S et, 23 °C, 72 h, A S T M D 3 9 5 - B
1 0 %
1 0 %
Bays h ore Re b o u n d Resilie nce, A S T M D 2 6 32
2 0 %
2 0 %
T h er m al Pr o p erti es
M etri c
U S
T g ( D M A, ta n( d)), A S T M D 4 0 6 5
1 0 ° C
5 0 ° F
Di el e ctri c/ El e ctri c Pr o p erti es
Dielectric C o nsta nt, A S T M D1 5 0
7. 6
Dissi pati o n Fact or, A S T M D1 5 0
0.1 5
G e n er al Pr o p erti es
Har d n ess, A S T M D22 4 0
3 5 (I nsta nt), 31 ( 5 s ec), S h ore A
D e nsity, A S T M D7 92
1. 07 g/c m3
D e nsity (li q ui d)
1. 0 5 g/c m3
2
T he
i nf or mati o n i n t his d oc u me nt
i ncl u d es val u es d eriv e d fr o m pri nti n g
vari o us
parts,
reflects
a n
a p pr oxi mati o n of t he mea n val u e of a
ra n ge of val u es, a n d is i nte n d e d f or
refere nce a n d c o m paris o n p ur p oses
o nly . T his i nf or mati o n s h o ul d n ot b e
use d f or testi n g, d esi g n s p ecificati o n
or q uality c o ntr ol p ur p oses . E n d -use
material p erf or ma nce ca n b e i m pacte d
by, 
b ut
n ot
li mite d
t o,
d esi g n,
pr ocessi n g, c ol or treat me nt, o p erati n g
a n d
e n d -use
c o n diti o ns,
test
c o n diti o ns, etc . Act ual val u es will vary
wit h
b uil d
c o n diti o ns. I n a d diti o n,
pr o d uct s p ecificati o ns are s u bject t o
c ha n ge wit h o ut n otice .
T his
i nf or mati o n
a n d
Car b o n’s
tec h nical a dvice are giv e n t o y o u i n
g o o d fait h b ut wit h o ut warra nty . T he
a p plicati o n,
use
a n d
pr ocessi n g
of
t hese a n d ot her Car b o n pr o d ucts by
y o u are b ey o n d Car b o n’s c o ntr ol a n d,
t heref ore,
e ntirely
y o ur
o w n
res p o nsi bility. Car b o n
pr o d ucts
are
o nly t o b e use d by y o u, s u bject t o t he
ter ms of t he writte n a gre e me nt by a n d
b et w e e n y o u a n d Car b o n .
Y o u are res p o nsi ble f or d eter mi ni n g
t hat t he Car b o n material is safe, la wf ul,
a n d
tec h nically
s uita ble
f or
t he
i nte n d e d a p plicati o n, as w ell
as f or
i d e ntifyi n g t he pr o p er dis p osal
( or
recycli n g)
met h o d
c o nsiste nt
wit h
a p plica ble
e nvir o n me ntal
la ws a n d
re g ulati o ns. C A R B O N
M A K E S
N O
W A R R A N TI E S
O F
A N Y
KI N D,
E X P R E S S E D
O R
I M P LI E D,
I N C L U DI N G, B U T N O T LI MI T E D T O,
T H E
W A R R A N TI E S
O F
M E R C H A N T A BI LI T Y, FI T N E S S F O R A
P A R TI C U L A R
U S E,
O R
N O N -
I N F RI N G E M E N T.
F urt her,
it 
is
ex pressly u n d erst o o d a n d a gre e d t hat
y o u
ass u me a n d
here by
ex pressly
release Car b o n fr o m all lia bility, i n t ort,
c o ntract
or ot her wise,
i nc urre d i n
c o n necti o n wit h
t he use of Car b o n
pr o d ucts,
tec h nical assista nce a n d
i nf or mati o n. N o lice nsewit h res p ect t o
a ny i ntellect ualpr o p erty is i m plie d.
Parts
w ere
pr ocesse d
usi n g
a n
M
series pri nter a n d a S mart Part Was her
wit h V F 1 as t he s olv e nt.

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
E xt e n d e d T D S
SI L 3 0
3

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
SI L 3 0 M e c h a ni c al Pr o p erti es
R e pr es e nt ati v e T e nsil e C ur v e 
A S T M D 412, Die C, 5 0 0 m m/ mi n
4
0
0. 5
1
1. 5
2
2. 5
3
3. 5
4
0
1 0 0
2 0 0
3 0 0
4 0 0
5 0 0
Str ess ( M P a)
El o n g ati o n ( %)
SI L 3 0

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
SI L 3 0 D y n a mi c M e c h a ni c al A n al ysis ( D M A)
D y na mic m ec ha nical a nalysis pr o vi d es i nsi g ht i nt o a mat erial’s visc o elastic pr o p erti es acr oss a ra n g e of t e m p erat ur es. T h e 
fi g ur e b el o w s h o ws a t e m p erat ur e ra m p of SI L 3 0. T h e p ea k i n t h e ta n( d) c ur v e i n dicat es t hat t h e glass tra nsiti o n t e m p erat ur e 
f or t his mat erial is a p pr oxi mat ely 1 0 °C. A r u b b er y plat ea u is o bs er v e d i n t h e st ora g e m o d ul us fr o m 2 0 – 1 5 0 ° C r efl ecti n g t h e 
elastic nat ur e of t his mat erial wit hi n t his t e m p erat ur e wi n d o w.
5
St a n d ar d:
St a n d ar d: A S T M D 4 0 6 5
I nstr u m e nt:
I nstr u m e nt: T A D M A Q 8 0 0
D M A M o d e
D M A M o d e : T e nsi o n
S a m pl e Di m e nsi o ns
S a m pl e Di m e nsi o ns :L = 2 0 m m, W =1 0 m m, t =1 m m (r ecta n g ular bl o c k)
Str ai n A m plit u d e:
Str ai n A m plit u d e: 0.1 % (li n ear r e gi m e of visc o elasticity)
Os cill ati o n fr e q u e n c y:
Os cill ati o n fr e q u e n c y: 1 Hz
T e m p er at ur e R a n g e:
T e m p er at ur e R a n g e: -1 0 0 º C t o 2 0 0 º C
R a m p R at e:
R a m p R at e: 1. 5 º C/ mi n
Pri nt C o n diti o ns:
Pri nt C o n diti o ns: All D M A sa m ples w er e pri nt e d usi n g s oft war e v1. 9. S a m pl es w er e ha n d- wi p e d a n d n ot was h e d wit h s olv e nt. T h e t h er m al c ur e f or all m at erials c o m pli es wit h 
t h e C ar b o n user ma n ual.

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
SI L 3 0 C h e mi c al C o m p ati bilit y 
* P er c e nt w ei g ht g ai n e d aft er 1 w e e k s u b m ersi o n f oll o wi n g A S T M D 5 4 3. V al u e s d o n ot r e pr e s e nt c h a n g e s i n di m e nsi o n or m e c h a ni c a l 
pr o p erti es.
M ass G ai n*
( %)
H o us e h ol d C h e mi c als
Bl e a c h ( N a Cl O , 5 %)
< 5 %
S a nitiz er ( N H 4Cl, 1 0 %)
5 – 1 5 %
Distill e d W at er
5 – 1 5 %
S u ns cr e e n ( B a n a n a B o at, S P F 5 0)
5 – 1 5 %
D et er g e nt ( Ti d e, Ori gi n al)
5 – 1 5 %
Wi n d e x P o w eriz e d F or m ul a
5 – 1 5 %
H y dr o g e n P er o xi d e ( 3 0 %)
1 5 – 3 0 %
Et h a n ol ( 9 5 %)
> 3 0 %
I n d ustri al Fl ui ds
E n gi n e Oil ( H a v oli n e S A E 5 W -3 0)
< 5 %
Br a k e Fl ui d ( C astr ol D O T -4)
> 3 0 %
Air pl a n e D ei ci n g Fl ui d ( T y p e I Et h yl e n e Gl y c ol)
< 5 %
Air pl a n e D ei ci n g Fl ui d ( T y p e I Pr o p yl e n e Gl y c ol)
5 – 1 5 %
Air pl a n e D ei ci n g Fl ui d ( T y p e I V Et h yl e n e Gl y c ol)
< 5 %
Air pl a n e D ei ci n g Fl ui d ( T y p e I V Pr o p yl e n e Gl y c ol)
5 – 1 5 %
Tr a ns missi o n Fl ui d ( H a v oli n e S y nt h eti c A T F)
< 5 %
E n gi n e C o ol a nt ( H a v oli n e X L C, 5 0 %/ 5 0 % pr e mi x e d)
< 5 %
Di es el ( C h e vr o n # 2)
1 5 – 3 0 %
G as oli n e ( C h e vr o n # 91)
> 3 0 %
S k y dr ol 5 0 0 B - 4
> 3 0 %
Str o n g A ci d/ B as e
S ulf uri c A ci d ( 3 0 %)
> 3 0 %
S o di u m H y dr o xi d e (1 0 %)
< 5 %
6

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
SI L 3 0 U V A gi n g
N at ural p oly m er a gi n g ca n occ ur i n t h e pr es e nc e of li g ht, s u n, a n d h eat.
C ar b o n e val u at e d t h e U V a gi n g p erf or ma nc e of SI L 
3 0 usi n g A S T M D 4 4 5 9, w hic h is i nt e n d e d t o si m ulat e i n d o or ex p os ur e of s olar ra diati o n t hr o u g h glass.
7
0
2 0
4 0
6 0
8 0
1 0 0
1 2 0
0
5 0
1 0 0
1 5 0
2 0 0
25 0
3 0 0
3 5 0
4 0 0
% of Ori gi n al El o n g ati o n at Br e a k
Ti m e E x p os e d ( h)
SI L 3 0 U V A gi n g
A S T M D 4 4 5 9:  Q- S u n X E -1, 0. 8 W/ m2 at 4 2 0 n m, 5 5 °C 
A S T M D 41 2:  Di e C, 5 0 0 m m/ mi n, av era g e v al u es r e pr es e nt e d

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
SI L 3 0 U V A gi n g
N at ural p oly m er a gi n g ca n occ ur i n t h e pr es e nc e of li g ht, s u n, a n d h eat.
C ar b o n e val u at e d t h e U V a gi n g p erf or ma nc e of SI L 
3 0 usi n g A S T M D 4 4 5 9, w hic h is i nt e n d e d t o si m ulat e i n d o or ex p os ur e of s olar ra diati o n t hr o u g h glass.
8
A S T M D 4 4 5 9:  Q- S u n X E -1, 0. 8 W/ m2 at 4 2 0 n m, 5 5 °C 
A S T M D 41 2:  Di e C, 5 0 0 m m/ mi n, av era g e v al u es r e pr es e nt e d
0 %
5 0 %
1 0 0 %
1 5 0 %
2 0 0 %
2 5 0 %
3 0 0 %
3 5 0 %
4 0 0 %
0
5 0
1 0 0
1 5 0
2 0 0
2 5 0
3 0 0
3 5 0
4 0 0
% of B as eli n e Pr o p ert y
Ti m e E x p os e d ( h)
SI L 3 0 U V A gi n g
M od ul u s ( C h or d, 1- 5 %)
T e nsile Str es s at 1 0 0 % El o n g ati o n
U T S
El o n g ati o n at Br ea k

© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d.
C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y
D oc #1 0 6 4 5 3- 0 0 R e v C
J u n e 1 0, 2 0 2 0
Bi oc o m pati bility T esti n g 
Pri nt e d parts w er e pr o vi d e d t o N A M S A f or e val uati o n i n acc or da nc e wit h I S O 1 0 9 9 3- 5 , Bi ol o gic al e val u ati o n of m e dic al d e vic es - P art 5: 
T ests f or i n vitr o c yt ot oxicit y , a n d I S O 1 0 9 9 3-1 0, Bi ol o gic al e val u ati o n of m e dic al d e vic es - P art 1 0: T ests f or irritati o n a n d s ki n 
s e nsitizati o n ( G P M T). Parts w er e pr oc ess e d usi n g a n M s eri es pri nt er a n d a S mart Part Was h er wit h V F 1 as t h e s ol v e nt. T h e r es ults f or all 
t ests i n dic at e d t hat SI L 3 0 pass e d t h e r e q uir e m e nts f or bi oc o m pati bility acc or di n g t o t h e a b o v e t ests. C ar b o n m a k es n o r e pr es e nt ati o n 
C ar b o n m a k es n o r e pr es e nt ati o n 
a n d is n ot r es p o nsi bl e f or t h e r es ults of a n y bi o c o m p ati bilit y t ests ot h er t h a n t h os e s p e cifi e d a b o v e.
a n d is n ot r es p o nsi bl e f or t h e r es ults of a n y bi o c o m p ati bilit y t ests ot h er t h a n t h os e s p e cifi e d a b o v e.
Discl ai m er
Bi oc o m pati bility r es ults ma y var y bas e d o n pri nti n g a n d/ or p ost- pr oc essi n g pr oc e d ur es.
S u bscri b er ac k n o wl e d g es t h e c o nt e nts of t his d oc u m e nt ar e s u bj e ct t o t h e T er ms a n d C o n diti o ns o utli n e d i n t h e S u bscri pti o n A g r e em e nt, 
i ncl u di n g t h e R estricti o ns o n Us e s e cti o n.
D O N O T U S E C A R B O N M A T E RI A L S I N M E DI C A L A P P LI C A TI O N S I N V O L VI N G I M P L A N T A TI O N I N T H E H U M A N B O D Y O R C O N T A C T 
WI T H B O D Y F L UI D S O R TI S S U E S U N L E S S T H E M A T E RI A L H A S B E E N P R O VI D E D F R O M C A R B O N U N D E R A W RI T T E N C O N T R A C T 
T H A T I S C O N SI S T E N T WI T H T H E C A R B O N P O LI C Y R E G A R DI N G M E DI C A L A P P LI C A TI O N S A N D E X P R E S S L Y A C K N O W L E D G E S T H E 
C O N T E M P L A T E D U S E. C A R B O N M A K E S N O R E P R E S E N T A TI O N, P R O MI S E, E X P R E S S W A R R A N T Y O R I M P LI E D W A R R A N T Y 
C O N C E R NI N G T H E S UI T A BI LI T Y O F T H E S E M A T E RI A L S F O R U S E I N I M P L A N T A TI O N I N T H E H U M A N B O D Y O R I N C O N T A C T WI T H 
B O D Y F L UI D S O R TI S S U E S. If C ar b o n has p er mitt e d i n t h e S u bscri pti o n A gr e e m e nt us e of t h e C ar b o n pri nt er f or a p plic ati o ns t hat r eq uir e 
bi oc o m pati bility, S u bscri b er ac k n o wl e d g es t hat it is t h e r es p o nsi bility of S u bscri b er, its r es p e cti v e c ust o m ers a n d e n d- us ers t o d et er mi n e 
t h e bi oc o m pati bility of all pri nt e d parts f or t h eir r es p e cti v e us es. 
C ar b o n, I nc. | w w w.c ar b o n 3 d.c o m 
1 0 8 9 Mills Wa y R e d w o o d City, C A 9 4 0 6 3 
1 ( 6 5 0) 2 8 5- 6 3 07
9
SI L 3 0 Bi o c o m p ati bilit y

  
 
 SI L 3 0 R e si n Bi o c o m p ati bilit y R e q uir e m e nt s  
A u g ust 2 0 1 7 
  
  
  
  
  
  
  
  
               1 
Bi o c o m p a ti bili t y R e q ui r e m e n t s 
 
S I L 3 0 R e si n: P ri n ti n g & P r o c e s si n g P r o t o c ol s f o r C a r b o n M S e ri e s P ri n t e r s 
 
T h e pr ot o c ol s d e s cri b e d i n t hi s d o c u m e nt w er e t e st e d b y C ar b o n f or pri nti n g p art s fr o m SI L 3 0 R e si n 
m at eri al s o t h at t h e y ar e s uit a bl e f or pr ol o n g e d s ki n c o nt a ct ( m or e t h a n 3 0 d a y s ) a n d s h ort -t er m m u c o s al -
m e m br a n e c o nt a ct ( u p t o 2 4 h o ur s ). 
 
F oll o w t h e i n str u cti o n s i n t hi s d o c u m e nt w h e n u si n g SI L 3 0 r e si n o n C ar b o n M 1 a n d M 2 pri nt er s t o e n s ur e 
bi o c o m p ati bilit y of t h e r e s ulti n g p art.   
 
R e si n Di s p e n si n g  
 
SI L 3 0 r e si n i s a t w o- c o m p o n e nt m at eri al s u p pli e d i n a d u al - c h a m b er, li g ht -r e si st a nt c artri d g e.  At pri nt 
ti m e, t h e A a n d B c o m p o n e nt s ar e mi x e d i n a 1 : 1 r ati o u si n g a st ati c mi x er ti p att a c h e d t o t h e e n d of t h e 
c artri d g e w hi c h i n st all e d i nt o a Al bi o n m ot ori z e d di s p e n si n g u nit. It i s s u g g e st e d t h at t h e i niti al v ol u m e 
( ~ 5 m L) of r e si n i s b ur n e d i nt o a w a st e c o nt ai n er t o pr e v e nt off - st oi c hi o m etr y. A n a p pr o pri at e v ol u m e of 
t h e mi x e d r e si n ( a s s p e cifi e d b y t h e pri nt pl a n n er s oft w ar e ) i s t h e n di s p e n s e d i nt o t h e pri nt er c a s s ett e a n d 
t h e c a s s ett e i s pl a c e d o n t h e o pti c al d e c k.   
 
N o t e : W h e n s wit c hi n g b et w e e n m at eri al s, t h e c a s s ett e s h o ul d b e cl e a n e d wit h i s o pr o p a n ol (I P A) t o e n s ur e 
t h at r e si d u al r e si n fr o m t h e pr e vi o u s pri nt i s n ot mi x e d wit h t h e SI L 3 0 r e si n . F or a d diti o n al i nf or m ati o n 
s e e t h e “ Cl e a ni n g t h e c a s s ett e ” s e cti o n of t h e U s er G ui d e.   
 
Pri nti n g 
 
A cl e a n e d b uil d pl atf or m i s i n st all e d o nt o t h e Z - st a g e a n d t h e pri nt pr o c e s s i niti at e d b y u pl o a di n g a 
s uit a bl e S T L, e nt eri n g r u n p ar a m et er s (r e si n t y p e, pri nt ori e nt ati o n, s u p p ort c o n str u cti o n, et c.) a n d 
r e q u e sti n g pri nt i niti ati o n.  Pri nt s p e e d a n d li g ht i nt e n sit y ar e c o ntr oll e d b y C ar b o n’ s pr o pri et ar y s oft w ar e 
t o e n s ur e p art a c c ur a c y a n d d e gr e e of U V n et w or k c ur e.   
 
P art R e m o v al fr o m B uil d Pl atf or m 
 
O n c e t h e “ gr e e n ” st at e p art ( o nl y t h e U V n et w or k i s c ur e d) i s b uilt, t h e b uil d pl atf or m i s r e m o v e d fr o m t h e 
pri nt er, t h e p art g e ntl y r e m o v e d fr o m t h e b uil d pl atf or m u si n g a v ari et y of s cr a p er s, t w e e z er s a n d bl a d e s .  
 
W a s hi n g 
 
R e m o v e e x c e s s r e si n u si n g s p o n g e s w a b s  a n d wi p e s a n d wit h c o m pr e s s e d air (i n a c a bi n et ) .  
 
W a s h t h e p art s wit h mil d a git ati o n i n V e r t r el X M ™, a n a z e otr o pi c mi xt ur e of 1, 1, 1, 2, 2, 3, 4, 5, 5, 5 -
D e c afl u or o p e nt a n e a n d m et h a n ol ( 9 1 - 9 3 t o 9 -7, w/ w, C h e m o ur s ™) f or 3 t o  5 mi n ut e s.  A git ati o n c a n b e 
a c hi e v e d b y pl a ci n g t h e p art s i n a st ai nl e s s st e el s m all - p art s b a s k et a n d r ot ati n g t h e b a s k et at 5 - 2 0 r p m i n 
s uffi ci e nt V ertr el X M ™ t o c o v er or u si n g t h e C ar b o n S m art P art W a s h er.  I n  t h e l att er c a s e, t h e w a s h er will 
pr o vi d e t h e pr o p er w a s h c y cl e.  
 
F or a d diti o n al i nf or m ati o n , s e e t h e “ W a s hi n g p art s ” s e cti o n of t h e U s er ’ s G ui d e.  
 
 
 
 
 
 

  
 
 SI L 3 0 R e si n Bi o c o m p ati bilit y R e q uir e m e nt s  
A u g ust 2 0 1 7 
  
  
  
  
  
  
  
  
               2 
 
S u p p ort R e m o v al 
 
S u p p ort s c a n b e r e m o v e d pri or t o w a s hi n g or aft er t h e w a s h a n d c ur e c y cl e s.  T o r e m o v e s u p p ort m at eri al 
fr o m t h e pri nt e d p art, u s e cl e a n t w e e z er s or cl e a n pr ot e cti v e gl o v e s.  
 
F or a d diti o n al i nf or m ati o n , s e e t h e “ R e m o vi n g s u p p ort s ” s e cti o n of t h e U s er ’ s G ui d e.   
 
T h er m al C ur e 
 
Pl a c e t h e p art s o n a n o n - sti c k tr a y. T h e n pl a c e t h e tr a y i n a cl e a n, d e di c at e d c o n v e cti o n o v e n at 1 2 0 ° C f or 
8  h o ur s.  
 
Bi o c o m p ati bilit y T e sti n g 
P art s pri nt e d a n d pr o c e s s e d a s o utli n e d i n t hi s d o c u m e nt w er e pr o vi d e d t o N A M S A  f or e v al u ati o n i n 
a c c or d a n c e wit h I S O 1 0 9 9 3 -5, Bi ol o gi c al e v al u ati o n of m e di c al d e vi c e s -  P art 5: T e st s f or i n vitr o 
c yt ot o xi cit y , a n d I S O 1 0 9 9 3 -1 0, Bi ol o gi c al e v al u ati o n of m e di c al d e vi c e s -  P art 1 0: T e st s f or irrit ati o n a n d 
s ki n s e n siti z ati o n  ( G P M T ) . T h e r e s ult s f or all t e st s i n di c at e d t h at SI L 3 0  re si n  p a s s e d t h e r e q uir e m e nt s f or 
bi o c o m p ati bilit y a c c or di n g t o t h e a b o v e t e st s.  C ar b o n m a k e s n o r e pr e s e nt ati o n a n d i s n ot r e s p o n si bl e f or 
t h e r e s ult s of a n y bi o c o m p atibilit y t e st s ot h er t h a n t h o s e s p e cifi e d a b o v e . 
Di s cl ai m e r 
Bi o c o m p ati bilit y r e s ult s m a y v ar y if pr ot o c ol s ar e u s e d ot h er t h a n t h o s e o utli n e d i n t hi s d o c u m e nt.  
 
S u b s cri b er a c k n o wl e d g e s t h e c o nt e nt s of t hi s d o c u m e nt ar e s u bj e ct t o t h e T er m s a n d C o n diti o n s o utli n e d 
i n t h e S u b s cri pti o n A gr e e m e nt, i n cl u di n g t h e R e stri cti o n s o n U s e s e cti o n.  
 
D O N O T U S E C A R B O N M A T E RI A L S I N M E DI C A L A P P LI C A TI O N S I N V O L VI N G I M P L A N T A TI O N I N T H E H U M A N 
B O D Y O R C O N T A C T WI T H B O D Y F L UI D S O R TI S S U E S U N L E S S T H E M A T E RI A L H A S B E E N P R O VI D E D F R O M 
C A R B O N U N D E R A W RI T T E N C O N T R A C T T H A T I S C O N SI S T E N T WI T H T H E C A R B O N P O LI C Y R E G A R DI N G 
M E DI C A L A P P LI C A TI O N S A N D E X P R E S S L Y A C K N O W L E D G E S T H E C O N T E M P L A T E D U S E. C A R B O N M A K E S 
N O R E P R E S E N T A TI O N, P R O MI S E, E X P R E S S W A R R A N T Y O R I M P LI E D W A R R A N T Y C O N C E R NI N G T H E 
S UI T A BI LI T Y O F T H E S E M A T E RI A L S F O R U S E I N I M P L A N T A TI O N I N T H E H U M A N B O D Y O R I N C O N T A C T 
WI T H B O D Y F L UI D S O R TI S S U E S. 
 
If C ar b o n h a s p er mitt e d i n t h e S u b s cri pti o n A gr e e m e nt u s e of t h e C ar b o n pri nt er f or a p pli c ati o n s t h at 
r e q uir e bi o c o m p ati bilit y, S u b s cri b er a c k n o wl e d g e s t h at it i s t h e r e s p o n si bilit y of S u b s cri b er, it s r e s p e cti v e 
c u st o m er s a n d e n d - u s er s t o d et er mi n e t h e bi o c o m p ati bilit y of all pri nt e d p art s f or t h eir r e s p e cti v e u s e s.   
 
C a r b o n, I n c.  | w w w. c ar b o n 3 d. c o m   
1 0 8 9 Mill s W a y 
R e d w o o d Cit y, C A 9 4 0 6 3 
1 ( 6 5 0) 2 8 5- 6 3 0 7 

T o u g h  1 5 0 0  St erili z ati o n  R e s ult s 
T h e  p ur p o s e  of  t hi s  p a p er  i s  t o  e v al u at e  t h e  c o m p ati bilit y  of  F or ml a b s  T o u g h  1 5 0 0  R e si n  wit h  v ari o u s  
bi ol o gi c al  st erili z ati o n  m et h o d s:   a ut o cl a v e,  g a m m a,  e- b e a m,  a n d  et h yl e n e  oxi d e  st erili z ati o n  ( Et O).  
C h a n g e s  i n  m e c h a ni c al  pr o p erti e s  will  b e  pr e s e nt e d  pr e-  a n d  p o st-  st erili z ati o n.    T h e  r e s ult s  pr e s e nt e d  ar e  
i nt e n d e d  t o  h el p  i nf or m  p ot e nti al  u s e s,  b ut  s h o ul d  n ot  b e  u s e d  a s  a  s u b stit ut e  f or  a p pli c ati o n- s p e ci ﬁc  
t e sti n g.   
S a m pl e  Pr e p ar ati o n  
Pri nti n g  
All  s a m pl e s  w er e  pri nt e d  o n  F or m  3 B  S L A  pri nt er s  e q ui p p e d  wit h  cl e a n  B uil d  Pl atf or m s,  F or m  3  R e si n  Ta n k s  
a n d  T o u g h  1 5 0 0  R e si n  V 4  c artri d g e s.  P art  ori e nt ati o n s  a n d  pl a c e m e nt  w er e  k e pt  c o n st a nt  f or  all  s a m pl e s.    
P o st  Pr o c e s si n g  
Aft er  pri nti n g,  t e sti n g  s a m pl e s  att a c h e d  t o  a  b uil d  pl atf or m  w er e  w a s h e d  t wi c e  i n  a  F or m  W a s h.  T h e  ﬁr st  
w a s h  w a s  1 0  mi n ut e s  i n  < = 9 5 %  I P A  t o  r e m o v e  t h e  m aj orit y  of  u n c ur e d  r e si n.  T h e  s e c o n d  w a s h  w a s  1 0  
mi n ut e s  i n  > 9 9 %  I P A  t o  e n s ur e  r e m o v al  of  a n y  r e si d u al  u n c ur e d  r e si n.  C o m pr e s s e d  air  w a s  u s e d  t o  dr y  t h e  
p art s  t h or o u g hl y.   P art s  w er e  r e m o v e d  fr o m  s u p p ort s  a n d  c ur e d  f or  6 0  mi n  at  7 0 o   C  i n  a  F or m  C ur e.   
F or ml a b s  F or m  W a s h,  F or m  C ur e,  a n d  ﬁni s hi n g  t o ol s  w er e  u s e d  a c c or di n g  t o  t h e  r e c o m m e n d e d  I n str u cti o n  
f or  U s e  t o  e n s ur e  o pti m al  p erf or m a n c e  a n d  bi o c o m p ati bilit y  c o m pli a n c e.   
R e s ult s  
Bi o c o m p ati bilit y  Te sti n g    
Pri nt e d  a n d  p o st- pr o c e s s e d  p art s  w er e  pr o vi d e d  t o  N A M S A  f or  I S O  1 0 9 9 3- 5,  Bi ol o gi c al  e v al u ati o n  of  
m e di c al  d e vi c e s  -  P art  5:  Te st s  f or  i n  vitr o  c yt ot oxi cit y  st u d y  u si n g  t h e  I S O  el uti o n  m et h o d.   T h e  r e s ult s  s h o w  
n o  e vi d e n c e  of  c a u si n g  c ell  l y si s  or  c yt ot oxi cit y;  wit h  0 %  l y si s  d et e ct e d.    
R e s ult s  a n d  c o n cl u si o n s  of  t h e  c yt ot oxi cit y  t e sti n g  ar e  b a s e d  o n  a  st a n d ar d  g e o m etr y  a n d  s a m pl e  s et  p er  
I S O  1 0 9 9 3- 5.   Bi o c o m p ati bilit y  a n d  st erili z ati o n  c o m p ati bilit y  r e s ult s  m a y  v ar y  if  t h er e  ar e  a n y  d e vi ati o n s  
fr o m  t h e  r e c o m m e n d e d  I n str u cti o n s  f or  u s e.   F or ml a b s  i s  n ot  r e s p o n si bl e  f or  a n y  bi o c o m p ati bilit y  r e s ult s  
e x c e pt  t h e  o n e  s p e ci ﬁe d  i n  t hi s  r e p ort.  U s er s  ar e  r e s p o n si bl e  f or  c o n ﬁr mi n g  bi o c o m p ati bilit y  f or  t h eir  
s p e ci ﬁc  a p pli c ati o n.   
M e c h a ni c al  Pr o p ert y  Te sti n g  
T e n sil e  T e sti n g:    Te n sil e  b ar s  ( A S T M  D 6 3 8  Ty p e  I)   w er e  pr e p ar e d  a s  d e s cri b e d  i n  t h e  “ S a m pl e  
Pr e s e nt ati o n”  s e cti o n.  T h e  s a m pl e s  w er e  c o n diti o n e d  a n d  t e st e d  a c c or di n g  t o  A S T M  D 6 3 8.   
 

Fl e x ur al  T e sti n g:    Fl e x ur al  b ar s  w er e  pr e p ar e d  a s  d e s cri b e d  i n  t h e  “ S a m pl e  Pr e p ar ati o n”  s e cti o n.  T h e  
s a m pl e s  w er e  c o n diti o n e d  a n d  t e st e d  a c c or di n g  t o  A S T M  D 7 9 0  -  M et h o d  B.   
P art s  pri nt e d  a n d  t e st e d  u n d er  di ﬀer e nt  c o n diti o n s,  s u c h  a s  pri nt er,  st or a g e  c o n diti o n s,  et c.  m a y  pr o d u c e  
di ﬀer e nt  r e s ult s.    
A ut o cl a v e  ( St e a m)  St erili z ati o n  
Te n sil e  a n d  ﬂe x ur al  b ar  s a m pl e s  w er e  pr o vi d e d  t o  S T E RI S  f or  a ut o cl a v e  pr o c e s si n g.   T h e  p art s  u n d er w e nt  
5  c y cl e s  of  pr e- v a c u u m  st e a m  st erili z ati o n  at  1 3 2 o   C  wit h  a  4- mi n ut e  st erili z ati o n  p h a s e  a n d  3 0  mi n ut e s  dr y  
p h a s e.   P art s  w er e  all o w e d  t o  c o ol  3 0  mi n ut e s  b et w e e n  c y cl e s.    
T h e  m e c h a ni c al  pr o p ert y  t e sti n g  b el o w  s h o w s  t h e  c o m p ati bilit y  of  T o u g h  1 5 0 0  R e si n  pri nt e d  p art s  wit h  
a ut o cl a v e  st erili z ati o n.   N o  a p pr e ci a bl e  l o s s e s  i n  m at eri al  pr o p erti e s,  d ef or m ati o n s,  cr a c ki n g  or  si g ni ﬁc a nt  
c h a n g e s  i n  c ol or  w er e  o b s er v e d  aft er  pr o c e s si n g.  Fl e x ur al  pr o p erti e s  w er e  t e st e d  a n d  f oll o w e d  si mil ar  
tr e n d s  a s  t e n sil e  t e sti n g.   
                C h a n g e  i n  Ulti m at e  Te n sil e  Str e n gt h  ( M P a)  
  C h a n g e  i n  Ulti m at e  Te n sil e  M o d ul u s  ( M P a)  
 
C h a n g e  i n  Str ai n  at  Br e a k  
 
 
 

G a m m a  St erili z ati o n  
Te n sil e  a n d  ﬂe x ur al  b ar  s a m pl e s  w er e  pr e p ar e d  a n d  pr o vi d e d  t o  St eri g e ni c s  -  R o c k a w a y,  N J  f or  G a m m a  
pr o c e s si n g.   T h e  s a m pl e s  w er e  e x p o s e d  t o  2 9. 4- 31. 2  k G y  of  g a m m a  r a di ati o n.  
P art s  w er e  pr o vi d e d  b a c k  t o  F or ml a b s  f or  m e c h a ni c al  pr o p ert y  t e sti n g  u si n g  A S T M  D 6 3 8  a n d  A S T M  D 7 9 0  
c o m pli a nt  m et h o d s.   T h e  m e c h a ni c al  pr o p ert y  t e sti n g  b el o w  s h o w s  t h e  c o m p ati bilit y  of  T o u g h  1 5 0 0  R e si n  
pri nt e d  p art s  wit h  g a m m a  st erili z ati o n.   N o  a p pr e ci a bl e  l o s s e s  i n  m at eri al  pr o p erti e s,  d ef or m ati o n s,  
cr a c ki n g  or  si g ni ﬁc a nt  c h a n g e s  i n  c ol or  w er e  o b s er v e d  aft er  pr o c e s si n g.  Fl e x ur al  pr o p erti e s  w er e  t e st e d  
a n d  f oll o w e d  si mil ar  tr e n d s  a s  t e n sil e  t e sti n g.    
                C h a n g e  i n  Ulti m at e  Te n sil e  Str e n gt h  ( M P a)  
  C h a n g e  i n  Ulti m at e  Te n sil e  M o d ul u s  ( M P a)  
   
 
C h a n g e  i n  Str ai n  at  Br e a k  
 
 
E- b e a m  St erili z ati o n  
Te n sil e  a n d  ﬂe x ur al  b ar  s a m pl e s  w er e  pr e p ar e d  a n d  pr o vi d e d  t o  St eri g e ni c s  -  S a n  Di e g o,  C A,   f or  e- b e a m  
pr o c e s si n g.   T h e  s a m pl e s  w er e  e x p o s e d  t o  a  s urf a c e  d o s e  of  3 5  k G y  of  e- b e a m  r a di ati o n.   
P art s  w er e  pr o vi d e d  b a c k  t o  F or ml a b s  f or  m e c h a ni c al  pr o p ert y  t e sti n g  u si n g  A S T M  D 6 3 8  a n d  A S T M  D 7 9 0  
c o m pli a nt  m et h o d s.   T h e  m e c h a ni c al  pr o p ert y  t e sti n g  b el o w  s h o w s  t h e  c o m p ati bilit y  of  T o u g h  1 5 0 0  R e si n  
pri nt e d  p art s  wit h  e- b e a m  st erili z ati o n.   N o  a p pr e ci a bl e  l o s s e s  i n  m at eri al  pr o p erti e s,  d ef or m ati o n s,  
cr a c ki n g  or  si g ni ﬁc a nt  c h a n g e s  i n  c ol or  w er e  o b s er v e d  aft er  pr o c e s si n g.  Fl e x ur al  pr o p erti e s  w er e  t e st e d  
a n d  f oll o w e d  si mil ar  tr e n d s  a s  t e n sil e  t e sti n g.   
 

  C h a n g e  i n  Ulti m at e  Te n sil e  Str e n gt h  ( M P a)  
  C h a n g e  i n  Ulti m at e  Te n sil e  M o d ul u s  ( M P a)  
C h a n g e  i n  Str ai n  at  Br e a k  
Et h yl e n e  O xi d e  ( Et O)  St erili z ati o n  
Te n sil e  a n d  ﬂe x ur al  b ar  s a m pl e s  w er e  pr e p ar e d  a n d  pr o vi d e d  t o  Bl u e  Li n e  St erili z ati o n  S er vi c e s  f or  Et O  
pr o c e s si n g.   T h e  s a m pl e s  w er e  c o n diti o n e d  at  5 5° C,  5 0 %  r el ati v e  h u mi dit y,  a n d  5 0  m b ar  f or  7 8  mi n ut e s.  
T h e  s a m pl e s  w er e  t h e n  e x p o s e d  t o  a  si n gl e  c y cl e  of  1 0 0 %  Et O  at  5 5° C  f or  1 8 0  mi n ut e s.  
P art s  w er e  pr o vi d e d  b a c k  t o  F or ml a b s  f or  m e c h a ni c al  pr o p ert y  t e sti n g  u si n g  A S T M  D 6 3 8  a n d  A S T M  D 7 9 0  
c o m pli a nt  m et h o d s.   T h e  m e c h a ni c al  pr o p ert y  t e sti n g  b el o w  s h o w s  t h e  c o m p ati bilit y  of  T o u g h  1 5 0 0  R e si n  
pri nt e d  p art s  wit h  Et O  st erili z ati o n.   N o  a p pr e ci a bl e  l o s s e s  i n  m at eri al  pr o p erti e s,  d ef or m ati o n s,  cr a c ki n g  or  
si g ni ﬁc a nt  c h a n g e s  i n  c ol or  w er e  o b s er v e d  aft er  pr o c e s si n g.  Fl e x ur al  pr o p erti e s  w er e  t e st e d  a n d  f oll o w e d  
si mil ar  tr e n d s  a s  t e n sil e  t e sti n g.   

C h a n g e  i n  Ulti m at e  Te n sil e  Str e n gt h  ( M P a)  
  C h a n g e  i n  Ulti m at e  Te n sil e  M o d ul u s  ( M P a)  
 
C h a n g e  i n  Str ai n  at  Br e a k  
 
 
DI S C L AI M E R:  T h e  d at a  pr e s e nt e d  i n  t hi s  r e p ort  a p pli e s  o nl y  t o  t h e  arti cl e s  t e st e d  b y  F or ml a b s.   F or ml a b s  
t a k e s  n o  r e s p o n si bilit y  f or  t e sti n g  c o m pl et e d  o n  c u st o m er’s  pr o d u ct s.  Bi o c o m p ati bilit y,  st erili z ati o n,  a n d  
m e c h a ni c al  c o m p ati bilit y  r e s ult s  m a y  v ar y  d e p e n di n g  o n  t h e  t e st  c o n diti o n s  a n d  pr ot o c ol  u s e d.    
 

Cl e a ni n g L a b  
Gl ass   
W PI s ells a n e w li n e of q u alit y b or osilic at e gl ass w ar e f or l a b or at ori es. T his 
articl e i ncl u d es i nf or m ati o n o n c ari n g f or y o ur gl ass w ar e.  
S o d a li m e gl ass is a s oft er gl ass a n d s h o ul d n ot b e us e d f or l a b or at or y p ur p os es, b ec a us e it c a n n ot e n d ur e t h e 
t e m p er at ur e or pr ess ur e c h a n g es of b or osilic at e gl ass, a n d it s h o ul d n ot b e a ut ocl a v e d at t h e hi g h 
t e m p er at ur es. M ost b ottl es ar e m a d e of s o d a li m e gl ass. T his articl e d e als wit h b or osilic at e gl ass. D o n ot mix 
s o d a li m e gl ass wit h b or osilic at e gl ass i n r ac ks w h e n y o u ar e cl e a ni n g or a ut ocl a vi n g.   
N e w Gl ass w ar e  
N e w gl ass w ar e is us u all y a littl e al k ali n e. Aft er i ns p ecti n g it f or cli ps a n d cr ac ks, w as h t h e gl ass i n w ar m, s o a p y 
w at er a n d t h e n s o a k it i n a s ol uti o n of 1 % H Cl or H N O 3 f or a s h ort p eri o d of ti m e. W as h t h e gl ass w ar e a g ai n 
a n d ri ns e it t h or o u g hl y wit h distill e d w at er.  
W h y Gl ass F ails  
W h e n l a b or at or y gl ass br e a ks u n d er n or m al us e, it is us u all y t h e r es ult of a c hi p, a br asi o n or scr atc h, or 
b ec a us e it w as ex p os e d t o q uic k t e m p er at ur e or pr ess ur e c h a n g es.  
I ns p ect y o ur l a b or at or y gl ass w ar e u p o n r ec ei pt a n d b ef or e us e. H ol d t h e gl ass u p t o n at ur al s u nli g ht 
a n d l o o k f or c hi ps, cr ac ks a n d fr act ur es. E v e n ti n y fr act ur es c a n c a us e t h e gl ass t o b r e a k u n d er pr ess ur e 
or i n el e v at e d t e m p er at ur es.  
A v oi d b u m pi n g gl ass w ar e a g ai nst a n yt hi n g ( ot h er gl ass w ar e, t h e si d e of t h e si n k, d es kt o p...). T his c a n 
c a us e ti n y fr act ur es or cr ac ks.  
T o a v oi d d a m a g e t o t h e gl ass, d o n ot s o a k it f or l o n g p eri o ds i n str o n g  al k ali n e s ol uti o ns.  
Pr o p er Cl e a ni n g Ti ps  
At a mi ni m u m, l a b or at ory gl ass s h o ul d b e fr e e of c h e mic al r esi d u e a n d gr e as e. D e p e n di n g o n y o ur ex p eri m e nt, 
it m a y als o n e e d t o b e st eriliz e d.  S o m e ti ps f or cl e a ni n g i ncl u d e:  
Us e a s oft bristl e br us h f or cl e a ni n g t o a v oi d u n n ec ess ar y scr atc h es.  
 N e v er us e h y dr ofl u oric aci d ( H F) t o cl e a n gl ass. A m o n g ot h er us es, H F is us e d as a d esc al er, a r ust 
r e m o v er, a m et al cl e a n er, a gl ass-etc h er a n d a m et al pl ati n g c o m p o u n d.It is hi g hl y c a ustic.  
N e v er us e str o n g al k ali s o a ps  or aci ds t o cl e a n gl ass.  
St a n d ar d b or osilic at e gl ass is a ut ocl a v e a bl e. If y o u a ut ocl a v e t h e gl ass, v e nt t h e a ut ocl a v e a n d l et it 
c o ol sl o wly. A ut ocl a v e at 2 3 0-2 4 0° C. F or s h ort p eri o ds of ti m e ( aft er a n extr e m e us e) it c a n b e 
a ut ocl a v e d at 4 0 0° C.  
As hi n g gl ass i n m ec h a nic al o v e ns o v er 5 0 0º C f or l o n g p eri o ds of ti m e will s h ort e n t h e lif e of y o ur 

gl ass w ar e.  
T o t est t h at a gl ass c o nt ai n er is f ull y w ett a bl e ( es p eci all y i m p ort a nt w h e n m a ki n g pr ecis e li q ui d 
m e as ur e m e nts), v erif y t h at distill e d w at er will w et all s urf ac es e q u all y.  
W as h all gl ass w ar e i m m e di at el y aft er us e t o r e m ov e all r esi d u es. If i m m e di at e cl e a ni n g is i m p ossi bl e, 
s o a k t h e gl ass w ar e. 
N e v er us e wir e br us h es or br us h es wit h a wir e c or e t o cl e a n gl ass w ar e.  
Alc o n o x is t h e b est cl e a n er f or gl ass. H o w e v er, a n o n-a br asi v e dis h s o a p als o w or ks w ell.  
Al w a ys ri ns e cl e a n gl ass w ar e w ell a n d f oll o w wit h a distill e d w at er ri ns e.  
Ci d e x is g o o d bi oci d e.  
R e m o v e gr e as e b y b oili n g t h e gl ass i n a w e a k s o di u m c ar b o n at e s ol uti o n. Or, us e ac et o n e. Ri ns e w ell 
wit h w at er.  
Ul tr as o nic cl e a ni n g is a n exc ell e nt c h oic e f or gl ass w ar e, es p eci all y w h e n it is c o m bi n e d wit h a h e at e d 
s ol uti o n of mil d d et er g e nt. 
St ai n R e m o v al  
St ai n  
 R e m o v al S ol uti o n  
P er m a n g a n at e 
Mix e q u al p arts of 3 % s ulf uric aci d wit h 3 % h y dr o g e n p er oxi d e  
Ir o n 
Mix o n e p art h y dr oc hl oric aci d wit h o n e p art w at er  
B act eri ol o gic al c o nt a mi n a nt  S o a k is disi nf ect a nt s ol uti o n li k e Ci d e x , st e a m a ut ocl a v e, w as h a n d ri ns e 
W h e n i n d o u bt, r ef er t o M S D S s h e ets f or cl e a ni n g s ol uti o ns t o d et er mi n e if t h e y will r e act wit h c h e mic als o n 
t h e gl ass w ar e. 
Dr yi n g Gl ass w ar e  
O v e n dr yi n g at 1 0 0° C is b est, b ut r ac k dr yi n g is fi n e. 
St e a m A ut ocl a vi n g 
A ut ocl a v e b or osilic at e gl ass w ar e f or 1 5 -2 0 mi n ut es at 1 0 0 -1 2 0º C. R e m o v e all cl os ur es, cl a m ps, cl as ps, etc. 
w h e n a ut ocl a vi n g. If it is n ot p ossi bl e t o r e m o v e t h e m, at l e ast l o os e n or  u nscr e w t h e m t o a v oi d pr ess ur e 
b uil d u p.  
Y o u c a n fi n d W PI's c o m pl et e li n e of gl ass w ar e pr o d ucts o n w pic h e mist y.c o m . If y o u h a v e q u esti o ns, pl e as e 
c o nt act H ei di at 8 6 6. 6 0 6. 1 9 7 4 or h ei di h @ w pii nc.c o m .  

S o d a -Li m e Gl a s s  
S o d a -Li m e Gl a s s  
Gl a s s F a bri c ati o n  
C o ati n g D e p o siti o n  
C N C M a c hi ni n g  
Str e n gt h e ni n g - C h e mi c al & H e at  
S cr e e n Pri nti n g of Gr a p hi c s  
S L G 1 0/ 2 1  
( 8 7 7) 6 2 2 -7 4 7 2   
w w w. a bri s at e c h n ol o gi e s. c o m  
i nf o @ a bri s at e c h n ol o gi e s. c o m 
A bri s a I n d u stri al Gl a s s  
2 0 0 S o ut h H all o c k Dri v e  
S a nt a P a ul a, C A 9 3 0 6 0  
Z C & R C o ati n g s f or O pti c s  
1 4 0 1 A b al o n e A v e n u e  
T orr a n c e, C A 9 0 5 0 1  
A bri s a T e c h n ol o gi e s, a m e m b er of H E F P h ot o ni c s, i s a  
gl o b all y r e c o g ni z e d t e c h n ol o g y gl a s s f a bri c ati o n a n d o pti c al 
t hi n fil m c o ati n g c o m p a n y wit h e x p erti s e i n hi g h v ol u m e 
m a n uf a ct uri n g a n d e n gi n e eri n g  c a p a biliti e s, d eli v eri n g T ot al 
S ol uti o n s t h at pr o vi d e e x c ell e nt p erf or m a n c e, fit n e s s -f or-u s e 
a n d e c o n o mi e s of s c al e.  
O ur U S b a s e d, st at e -of -t h e-art I S O 9 0 0 1: 2 0 1 5 a n d I T A R 
r e gi st er e d f a ciliti e s i n cl u d e A bri s a I n d u stri al Gl a s s i n S a nt a 
P a ul a, C A a n d Z C & R C o ati n g s f or O pti c s i n T orr a n c e C A. 
T h e s e t w o di vi si o n s pr o d u c e s ol uti o n s fr o m c ut -t o-or d er 
c o at e d gl a s s c o m p o n e nt s t o c u st o m c o m pl e x a n d         
r e a d y-t o-i n st all f a bri c at e d, str e n gt h e n e d, o pti c all y c o at e d, 
el e ctr o ni c all y e n a bl e d a n d br a n d e d s u b -a s s e m bli e s.  
O ur T ot al S ol uti o n s s er v e a v ari et y of  m ar k et s i n cl u di n g  
Mi cr o -El e ctr o ni c s, D ef e n s e a n d A vi o ni c s, Di s pl a y, I n d u stri al 
A ut o m ati o n, O pti c al S e n s or s, I m a gi n g, P h ot o ni c s, M e di c al  
& D e nt al, Lif e S ci e n c e a n d m or e.  
Cl e ar & Ti nt e d S o d a -Li m e Gl a s s pr o vi d e s hi g h li g ht 
tr a n s mi s si o n, c a n b e A R c o at e d f or s u p er hi g h        
tr a n s mi s si o n, c a n b e c h e mi c all y str e n gt h e n e d, a n d 
h a s g o o d fl at n e s s.  
S o d a -li m e gl a s s i s t h e m o st  pr e v al e nt t y p e of gl a s s 
a n d i s pr e p ar e d b y m elti n g h e r a w m at eri al s, s u c h 
a s s o d a, li m e, sili c a, al u mi n a, a n d s m all q u a ntiti e s  
of fi ni n g a g e nt s i n a gl a s s f ur n a c e at t e m p er at ur e s          
u p t o 1 6 7 5° C.  
S o d a -Li m e s h e et gl a s s i s m a d e b y fl o ati n g m olt e n 
gl a s s o n a b e d of m olt e n ti n. T hi s m et h o d gi v e s t h e 
s h e et u nif or m t hi c k n e s s a n d v er y fl at s urf a c e s.           
S o d a -li m e gl a s s i s t h e b a s e m at eri al f or m o st cl e ar, 
c ol or e d a n d p att er n e d gl a s s t y p e s.  
A bri s a T e c h n ol o gi e s ● 2 0 0 S o ut h H all o c k Dri v e, S a nt a P a ul a, C A 9 3 0 6 0 ● ( 8 7 7) 6 2 2 -7 4 7 2   
w w w. a bri s at e c h n ol o gi e s. c o m ● i nf o @ a bri s at e c h n ol o gi e s. c o m 
Y o ur T ot al S ol uti o n P art n er  
Di m e n si o n s:  
 
•  
T hi c k n e s s e s: 0. 0 2” –  1” ( 0. 5 5 m m –  2 5. 4 m m)  
•  
Si z e s: U p t o 9 6” x 7 2” ( 2 4 4 0 m m x 1 8 3 0 m m) 
•  
Ot h er si z e s m a y b e a v ail a bl e u p o n r e q u e st  
S o d a -Li m e Gl a s s i s:  
•  
L e s s E x p e n si v e t h a n ot h er gl a s s wit h s p e ci ali z e d 
pr o p erti e s s u c h a s b or o sili c at e s a n d al u mi n o sili-
c at e s.  
•  
S o d a -Li m e gl a s s i s c h e mi c all y st a bl e, pr e v e nti n g 
c orr o si o n a n d t h er ef or e c h e mi c all y c o m p ati bl e.  
•  
S o d a -Li m e i s a h ar d gl a s s, s o it h a s s o m e         
a br a si o n r e si st a n c e, a n d m or e s o if c h e mi c all y 
str e n gt h e n e d.  
•  
If h e at t e m p er e d, s o d a-li m e gl a s s c a n b e l e s s        
v ul n er a bl e t o t h er m al s h o c k.  
•  
S o d a -Li m e gl a s s i s a g o o d i n s ul at or a s it d o e s          
n ot tr a n s mit el e ctri cit y w ell d u e t o it s hi g h           
s p e cifi c r e si sti vit y a n d l o w di el e ctri c c o n st a nt.  
•  
S o d a -Li m e gl a s s i s hi g hl y tr a n s mi s si bl e m a ki n g         
it a n e x c ell e nt c h oi c e w h er e li g ht tr a n s mi s si o n i s 
r e q uir e d. 

S o d a -Li m e Gl a s s  
* M e c h a ni c al str e n gt h i s t h e g e n er al a bilit y of a m at eri al t o wit ht a n d str e s s a n d str ai n. T h e m e c h a ni c al str e n gt h of   t e m p er e d  or              
c h e mi c all y str e n gt h e n e d gl a s s c a n b e 4 ti m e s a s m u c h a s or di n ar y gl ass.   
S o d a -Li m e Gl a s s  
 
O pti o n s  
C o ati n g s:  
•  
C u st o m V -C o at, M ulti -b a n d, Br o a d b a n d A R  
•  
A R C o ati n g s t o  MI L -C -1 4 8 0 6 A  
•  
I T O/I MI T O f or E MI S hi el di n g, H e at er, L C D e vi c e s 
•  
C u st o m S W P, L W P, B a n d p a s s, U V & NI R Bl o c k er  
•  
Br o a d/ N arr o w b a n d S c a n ni n g Mirr or C o ati n g s  
•  
D e p o siti o n o nt o Filt er s, Sili c o n & Ot h er M at eri al s  
•  
A ut o cl a v a bl e, Bi o or C h e mi c all y C o m p ati bl e  
S u b str at e s:  
•  
F a bri c ati o n t o S h a p e & Si z e  
       - C ut & S e a m or Cir cl e Gr o u n d t o Si z e & S h a p e  
       - Pr e ci si o n C N C - H ol e s, B e v el s, St e p s, N ot c h e s  
•  
D a m a g e R e si st a nt S u b str at e s  
      -  HI E ™ Al u mi n o sili c at e s  
          - A G C Dr a g o ntr ail ™ 
          - C or ni n g ®  G orill a ®  
          - S C H O T T A S 8 7  
      - C h e mi c all y Str e n gt h e n e d S o d a Li m e Fl o at  
•  
L o w E x p a n si o n C h e mi c all y R e si st a nt S u b str at e s  
      - S C H O T T B or ofl o at ®  3 3  
•  
Ultr a T hi n a n d W af er S u b str at e s  
      - A G C E N -A 1  
      - C or ni n g ®  E a gl e X G ®  
      - S C H O T T A F 3 2, D 2 6 3 ®  & A S 8 7  
•  
Ot h er  
    -  A p pli e d Fil m s & Ti nt s  
    -  G a s k et A p pli c ati o n  
    -  E d g e Tr e at m e nt/ Bl a c k e ni n g  
    -  L a s er M ar ki n g ( Q R & B ar c o d e s, S/ N)  
E a s y -t o-Cl e a n & A nti -F o g S ol uti o n s:  
•  
Ol e o/ H y dr o p h o bi c O pti o n s  
•  
I T O H e at er, H T A F A nti-F o g S ol uti o n s  
Gr a p hi c s & B u s B ar s:  
•  
C ol or M at c h e d E p o x y I n k  
•  
N o n -C o n d u cti v e I n k  
•  
Hi g h T e m p er at ur e Frit I n k  
•  
D e a dfr o nt I n k - P arti all y Tr a n s mi s si v e  
•  
I nfr ar e d I R Tr a n s mitti n g I n k 
•  
Sil v er E p o x y, Sil v er Frit, Cr Ni A u B u s B ar s  
T h er m al Pr o p erti e s  
M e a s ur e m e nt  
E x pl a n ati o n  
T h er m al C o effi ci e nt of         
E x p a n si o n  
( 0/ 3 0 0° C): 8. 6 x 1 0-6 /° C 
H o w m u c h a m at eri al ’s v ol u m e  
c h a n g e s a s it h e at s or c o ol s  
A n n e ali n g P oi nt  
1 0 1 5° F/ 5 4 6° C  
T h e t e m p er at ur e w h er e r e si d u al 
str e s s i n a m at eri al i s r e d u c e d  
wit hi n s e v er al mi n ut e s  
S oft e ni n g P oi nt  
3 4 0° F/ 7 2 6° C  
T h e t e m p er at ur e at w hi c h a           
m at eri al sl u m p s u n d er it s o w n 
w ei g ht  
Str ai n P oi nt  
9 5 7° F/ 5 1 4° C  
T h e t e m p er at ur e w h er e r e si d u al 
str e s s i n a m at eri al i s r e d u c e d  
wit hi n s e v er al h o ur s  
M e c h a ni c al Pr o p erti e s  
M e a s ur e m e nt  
E x pl a n ati o n  
D e n sit y  
2. 4 4 g/ c m 3 @ 2 0° C/ 6 8° F  
M a s s p er u nit of v ol u m e  
K n o o p H ar d n e s s  
5 8 5 K g/ m m 2  + 2 0  
M e a s ur e s h ar d n e s s a n d r e si st a n c e 
t o i n d e nt ati o n 
H ar d n e s s M o h s S c al e  
6 -7  
M e a s ur e s s cr at c h r e si st a n c e  
M o d ul u s of El a sti cit y 
( Y o u n g’s)  
7. 2 x 1 0 1 0 P a  
H o w stiff a m at eri al i s  
M o d ul u s of Ri gi dit y  
3. 0 x 1 0 1 0 P a  
H o w m u c h s h e ar a m at eri al c a n 
h a n dl e  
B ul k M o d ul u s  
4. 3 x 1 0 1 0 P a  
H o w c o m pr e s si o n -r e si st a nt a           
m at eri al i s  
P oi s s o n ’s R ati o  
. 2 2 
H o w m u c h a m at eri al str et c h e s i n 
o n e dir e cti o n a n d n arr o w s i n a n ot h-
er w h e n it ’s p ull e d i n t w o diff er e nt 
dir e cti o n s  
O pti c al Pr o p erti e s  
M e a s ur e m e nt  
E x pl a n ati o n  
R efr a cti v e I n d e x  
•  
1 µ m, 2 µ m  
 
1. 5 2 3 ( 4 3 5 n m), 1. 5 1 3 ( 6 4 5 n m)  
T h e m e a s ur e m e nt of h o w m u c h 
li g ht p a s s e s t hr o u g h a m at eri al          
i n st e a d of b ei n g r efl e ct e d  
C h e mi c al Pr o p erti e s  
M e a s ur e m e nt  
E x pl a n ati o n  
H y dr ol yti c R e si st a n c e  
Cl a s s 3  
H o w li k el y a m at eri al i s t o c o nt a mi-
n at e c h e mi c al s i n c o nt a ct wit h it     
(it s c h e mi c al d ur a bilit y)  
A ci d R e si st a n c e  
N/ A  
 
Al k ali R e si st a n c e  
N/ A  
 
El e ctri c al Pr o p erti e s  
M e a s ur e m e nt  
Di el e ctri c C o n st a nt  
H o w m u c h a m at eri al i s 
aff e ct e d  b y a m a g n eti c 
fi el d  
7. 7 5 @ 2 0° C E  
S p e cifi c R e si sti vit y  
H o w w ell a m at eri al                 
r e si st s c o n d u cti n g                  
el e ctri cit y  
7. 9 4 x 1 0 1 7  t o            
7. 9 4  x 1 0 1 8 
µ o h m· c m  
F e at ur e s:  
•  
C a n b e c h e mi c all y str e n gt h e n e d t o i n cr e a s e          
m e c h a ni c al str e n gt h*  
•  
C a n b e h e at str e n gt h e n e d or h e at t e m p er e d t o  
i n cr e a s e t h er m al s h o c k r e si st a n c e a n d                          
m e c h a ni c al str e n gt h  
•  
C a n b e m a c hi n e d, o pti c all y c o at e d, c h e mi c all y 
et c h e d, s a n d bl a st e d, c ol or e d, or l a mi n at e d  
•  
G o o d fl at n e s s a n d s urf a c e q u alit y d u e t o fl o at       
pr o c e s s  
•  
T h e l o w e st c o st s ol uti o n f or s h e et f a bri c ati n g           
gl a s s c o m p o n e nt s  

FOR US PRODUCED CA 435 ONLY

T e c h ni c al D at a S h e et
L O C TI T E ® 4 3 5 ™
D e c e m b er -2 0 2 0
P R O D U C T D E S C RI P TI O N
L O C TI T E ®
4 3 5 ™ 
pr o vi d e s 
t h e 
f oll o wi n g 
pr o d u ct
c h ar a ct eri sti c s:
T e c h n ol o g y
C y a n o a cr yl at e
C h e mi c al T y p e 
Et h yl c y a n o a cr yl at e
A p p e ar a n c e ( u n c ur e d)  
C ol orl e s s t o
str a w
c ol or e d,
sli g htl y
cl o u d y li q ui d L M S
C o m p o n e nt s
O n e p art - r e q uir e s n o mi xi n g
Vi s c o sit y
L o w
C ur e
H u mi dit y
A p pli c ati o n
B o n di n g
K e y S u b str at e s  
M et al s , Pl a sti c s a n d R u b b er s
L O C TI T E ®
4 3 5 ™i s
a
r u b b er
t o u g h e n e d
a d h e si v e
wit h
i n cr e a s e d fl e xi bilit y
a n d
p e el str e n gt h
al o n g
wit h
e n h a n c e d
r e si st a n c e t o s h o c k. T h e pr o d u ct pr o vi d e s r a pi d b o n di n g o n a
wi d e
r a n g e
of
m at eri al s, i n cl u di n g
m et al s, 
pl a sti c s
a n d
el a st o m er s,
a s
w ell
a s
p or o u s a n d
a b s or b e nt
m at eri al s li k e
w o o d, p a p er, l e at h er a n d f a bri c.
I S O- 1 0 9 9 3
L O C TI T E ® 4 3 5 ™h a s b e e n t e st e d t o
H e n k el' s t e st pr ot o c ol s
b a s e d o n I S O 1 0 9 9 3 bi o c o m p ati bilit y st a n d ar d s, a s a
m e a n s t o
a s si st i n t h e s el e cti o n of pr o d u ct s f or u s e i n t h e
m e di c al d e vi c e
i n d u str y.
T Y PI C A L P R O P E R TI E S O F U N C U R E D M A T E RI A L
S p e cifi c Gr a vit y
@ 2 5 ° C
1. 1
Fl a s h P oi nt - S e e S D S
Vi s c o sit y, C o n e & Pl at e, m P a· s ( c P):
T e m p er at ur e: 2 5 ° C, S h e ar R at e: 1, 0 0 0 s - 1
1 0 0 t o 2 5 0 L M S
T Y PI C A L C U RI N G P E R F O R M A N C E
U n d er n or m al c o n diti o n s, t h e at m o s p h eri c
m oi st ur e i niti at e s t h e
c uri n g pr o c e s s.
Alt h o u g h f ull f u n cti o n al str e n gt h i s d e v el o p e d
i n a r el ati v el y s h ort ti m e, c uri n g c o nti n u e s f or at l e a st 2 4 h o ur s
b ef or e f ull c h e mi c al/ s ol v e nt r e si st a n c e i s d e v el o p e d.
C ur e S p e e d v s. S u b str at e
T h e r at e of c ur e will d e p e n d o n t h e s u b str at e u s e d. T h e t a bl e
b el o w s h o w s t h e fi xt ur e ti m e a c hi e v e d o n diff er e nt
m at eri al s at
2 2 ° C / 5 0
% r el ati v e h u mi dit y. T hi s i s d efi n e d a s t h e ti m e t o
d e v el o p a s h e ar str e n gt h of 0. 1 N/ m m ².
Fi xt ur e Ti m e, s e c o n d s:
St e el ( d e gr e a s e d)
3 0 t o 4 5
Al u mi n u m (I s o pr o p a n ol wi p e d)
≤6 0 L M S
Zi n c di c hr o m at e
9 0 t o 1 0 5
N e o pr e n e
3 0 t o 4 5
R u b b er, nitril e
< 5
S B R
9 0 t o 1 0 5
A B S
1 0 t o 2 0
P V C
6 0 t o 7 5
P ol y c ar b o n at e
4 5 t o 6 0
P h e n oli c
1 0 t o 2 0
G- 1 0 E p o x y
4 5 t o 6 0
W o o d ( o a k)
7 5 t o 9 0
W o o d ( b al s a)
< 5
C ur e S p e e d v s. B o n d G a p
T h e r at e of c ur e
will d e p e n d o n t h e b o n dli n e g a p.
T hi n b o n d
li n e s r e s ult i n hi g h c ur e s p e e d s, i n cr e a si n g t h e b o n d g a p
will
d e cr e a s e t h e r at e of c ur e.
C ur e S p e e d v s. A cti v at or
W h er e c ur e s p e e d i s u n a c c e pt a bl y l o n g d u e t o l ar g e g a p s,
a p pl yi n g
a cti v at or t o t h e s urf a c e
will i m pr o v e c ur e
s p e e d.
H o w e v er, t hi s c a n r e d u c e ulti m at e str e n gt h of t h e b o n d a n d
t h er ef or e t e sti n g i s r e c o m m e n d e d t o c o nfir m eff e ct.
C ur e S p e e d v s. Ti m e
T h e
gr a p h
b el o w s h o w s t h e s h e ar str e n gt h
d e v el o p e d o v er
ti m e at 2 2 ° C / 5 0
%
R H o n v ari o u s s u b str at e s a n d t e st e d
a c c or di n g t o I S O 4 5 8 7.
Str e n gt h, N/ m m ²
C ur e Ti m e,
mi n ut e s
7
6
5
4
3
2
1
0
0 
1 0 
2 0 
3 0 
4 0 
5 0
St e el
Al u mi n u m
P ol y c ar b o n at e
P V C
G- 1 0 E p o x y
P h e n oli c
F or t h e
m o st dir e ct a c c e s s t o l o c al s al e s a n d t e c h ni c al s u p p ort vi sit:
w w w. h e n k el. c o m/i n d u stri al

T D S L O C TI T E ® 4 3 5 ™,
D e c e m b er -2 0 2 0
T Y PI C A L P R O P E R TI E S O F C U R E D M A T E RI A L
C ur e d f or 2 4 h o ur s
@ 2 2° C
P h y si c al Pr o p erti e s :
C o effi ci e nt of T h er m al E x p a n si o n,
I S O 1 1 3 5 9- 2, K- 1
8 0 × 1 0 - 6
C o effi ci e nt of T h er m al C o n d u cti vit y I S O 8 3 0 2,
W/( m· K)
0. 1
Gl a s s Tr a n siti o n T e m p er at ur e I S O 1 1 3 5 9- 2, ° C 
1 3 0
El e ctri c al Pr o p erti e s :
S urf a c e R e si sti vit y, I E C 6 0 0 9 3, Ω
1 0 × 1 0 1 5
V ol u m e R e si sti vit y, I E C 6 0 0 9 3, Ω· c m
1 0 × 1 0 1 5
Di el e ctri c Br e a k d o w n Str e n gt h,
I E C 6 0 2 4 3- 1, k V/ m m
2 5
Di el e ctri c C o n st a nt / Di s si p ati o n F a ct or, I E C 6 0 2 5 0:
0. 1 -k H z
2. 6 5 / < 0. 0 2
1 -k H z
2. 7 5 / < 0. 0 2
1 0 -k H z
2. 7 5 / < 0. 0 2
T Y PI C A L P E R F O R M A N C E O F C U R E D M A T E RI A L
A d h e si v e Pr o p erti e s
C ur e d f or 2 4 h o ur s
@ 2 2° C
L a p S h e ar Str e n gt h :
St e el ( grit bl a st e d)
N/ m m ² 
1 9
( p si) 
( 2, 7 0 0)
Al u mi n u m
N/ m m ² 
1 5
( p si) 
( 2, 2 0 0)
Nitril e
N/ m m ² 
0. 4
( p si) 
( 6 0)
E P D M
N/ m m ² 
0. 5
( p si) 
( 8 0)
Bl o c k S h e ar Str e n gt h, I S O 1 3 4 4 5:
A B S
N/ m m ² 
1 4
( p si) 
( 2, 0 0 0)
P V C
N/ m m ² 
9
( p si) 
( 1, 3 0 0)
P ol y c ar b o n at e
N/ m m ² 
6
( p si) 
( 8 4 0)
P h e n oli c
N/ m m ² 
1 3
( p si) 
( 1, 8 0 0)
G- 1 0 E p o x y
N/ m m ² 
2 0
( p si) 
( 2, 9 0 0)
T e n sil e Str e n gt h, I S O 6 9 2 2:
St e el ( grit bl a st e d)
N/ m m ² 
3 0
( p si) 
( 4, 4 0 0)
B u n a- N
N/ m m ² 
3
( p si) 
( 4 0 0)
Si d e I m p a ct R e si st a n c e, , J:
Al u mi n u m
≥4 L M S
C ur e d f or 4 8 h o ur s
@ 2 2° C
L a p S h e ar Str e n gt h :
St e el ( grit bl a st e d)
N/ m m ² 
≥1 5 L M S
( p si) 
( ≥2, 1 7 5)
1 8 0° P e el Str e n gt h, I S O 8 5 1 0- 2:
St e el ( grit bl a st e d)
N/ m m 
4
(l b/i n) 
( 2 0)
T Y PI C A L E N VI R O N M E N T A L
R E SI S T A N C E
C ur e d f or 7 2 h o ur s
@ 2 2° C
L a p S h e ar Str e n gt h I S O 4 5 8 7:
St e el ( grit bl a st e d)
H ot Str e n gt h
T e st e d at t e m p er at ur e
% Str e n gt h
@ 2 2 ° C
T e m p er at ur e, ° C
1 0 0
7 5
5 0
2 5
0
0
5 0
1 0 0
1 5 0
H e at A gi n g
A g e d at t e m p er at ur e i n di c at e d a n d t e st e d
@ 2 2 ° C
% Str e n gt h
@ 2 2 ° C
E x p o s ur e Ti m e, h o ur s
1 2 5
1 0 0
7 5
5 0
2 5
0
0
5 0 0 
1 0 0 0 
1 5 0 0 
2 0 0 0
8 0 ° C
1 0 0 ° C
1 2 1 ° C
H e at A gi n g/ H ot Str e n gt h
A g e d u n d er c o n diti o n s i n di c at e d a n d t e st e d at t e m p er at ur e
% Str e n gt h
@ 2 2 ° C
E x p o s ur e Ti m e, h o ur s
1 0 0
7 5
5 0
2 5
0
0
1 0 0
5 0 0
1 0 0 0
8 0 ° C
1 0 0 ° C
1 2 1 ° C
C h e mi c al/ S ol v e nt R e si st a n c e
A g e d u n d er c o n diti o n s i n di c at e d a n d t e st e d
@ 2 2 ° C
% of i niti al str e n gt h
E n vir o n m e nt
° C 
1 0 0 h 
5 0 0 h 
1 0 0 0 h
M ot or oil
4 0 
1 0 0 
1 0 0 
1 0 0
G a s oli n e
2 2 
1 0 0 
1 0 0 
9 0
Et h a n ol
2 2 
1 0 0 
1 0 0 
1 0 0
I s o pr o p a n ol
2 2 
1 0 0 
1 0 0 
1 0 0
H e at/ h u mi dit y 9 5 % R H 
4 0 
1 0 0 
1 0 0 
1 0 0
C ur e d f or 7 2 h o ur s
@ 2 2° C
Bl o c k S h e ar Str e n gt h, I S O 1 3 4 4 5:
P ol y c ar b o n at e
C h e mi c al/ S ol v e nt R e si st a n c e
A g e d u n d er c o n diti o n s i n di c at e d a n d t e st e d
@ 2 2 ° C.
% of i niti al str e n gt h
F or t h e
m o st dir e ct a c c e s s t o l o c al s al e s a n d t e c h ni c al s u p p ort vi sit:  
w w w. h e n k el. c o m/i n d u stri al

T D S L O C TI T E ® 4 3 5 ™,
D e c e m b er -2 0 2 0
E n vir o n m e nt
° C 
1 0 0 h 
5 0 0 h 
1 0 0 0 h
H e at/ h u mi dit y 9 5 % R H 
4 0 
1 0 0 
1 0 0 
1 0 0
G E N E R A L I N F O R M A TI O N
T hi s pr o d u ct i s n ot r e c o m m e n d e d f or u s e i n p ur e o x y g e n a n d/ or
o x y g e n ri c h s y st e m s a n d s h o ul d n ot b e s el e ct e d a s a s e al a nt f or
c hl ori n e or ot h er str o n g o xi di zi n g
m at eri al s.
F or s af e h a n dli n g i nf or m ati o n o n t hi s pr o d u ct, c o n s ult t h e S af et y
D at a S h e et ( S D S).
Dir e cti o n s f or u s e
1. F or b e st p erf or m a n c e b o n d s urf a c e s s h o ul d b e cl e a n a n d fr e e
fr o m gr e a s e.
2. T hi s pr o d u ct p erf or m s b e st i n t hi n b o n d g a p s ( 0. 0 5
m m).
3. E x c e s s a d h e si v e c a n b e di s s ol v e d wit h L o ctit e cl e a n u p s ol v e nt s,
nitr o m et h a n e or a c et o n e.
L o ctit e
M at eri al S p e cifi c ati o n L M S
L M S d at e d  N o v e m b er -0 1, 2 0 0 5.
T e st r e p ort s f or e a c h b at c h ar e
a v ail a bl e f or t h e i n di c at e d
pr o p erti e s. 
L M S t e st r e p ort s i n cl u d e
s el e ct e d
Q C t e st p ar a m et er s c o n si d er e d a p pr o pri at e t o s p e cifi c ati o n s
f or c u st o m er u s e.
A d diti o n all y, c o m pr e h e n si v e c o ntr ol s ar e i n pl a c e t o
a s s ur e 
pr o d u ct 
q u alit y 
a n d 
c o n si st e n c y. 
S p e ci al 
c u st o m er
s p e cifi c ati o n r e q uir e m e nt s m a y b e c o or di n at e d t hr o u g h H e n k el Q u alit y.
St or a g e
St or e pr o d u ct i n t h e u n o p e n e d c o nt ai n er i n a dr y l o c ati o n.
St or a g e
i nf or m ati o n
m a y b e i n di c at e d o n t h e pr o d u ct c o nt ai n er l a b eli n g.
O pti m al St or a g e:
2 ° C t o 8 ° C.
St or a g e b el o w 2 ° C or gr e at er t h a n
8 ° C c a n a d v er s el y aff e ct pr o d u ct pr o p erti e s. M at eri al r e m o v e d fr o m
c o nt ai n er s
m a y b e c o nt a mi n at e d d uri n g u s e.
D o n ot r et ur n pr o d u ct t o
t h e 
ori gi n al 
c o nt ai n er.
H e n k el  
C or p or ati o n 
c a n n ot 
a s s u m e
r e s p o n si bilit y f or pr o d u ct w hi c h h a s b e e n c o nt a mi n at e d or st or e d u n d er
c o n diti o n s 
ot h er t h a n t h o s e 
pr e vi o u sl y i n di c at e d. If 
a d diti o n al
i nf or m ati o n 
i s 
r e q uir e d, 
pl e a s e 
c o nt a ct 
y o ur 
l o c al  
H e n k el
r e pr e s e nt ati v e.
C o n v er si o n s
(° C x 1. 8) + 3 2 = ° F
k V/ m m x 2 5. 4 = V/ mil
m m / 2 5. 4 = i n c h e s
µ m / 2 5. 4 = mil
N x 0. 2 2 5 = l b
N/ m m x 5. 7 1 = l b/i n
N/ m m ² x 1 4 5 = p si
M P a x 1 4 5 = p si
N· m x 8. 8 5 1 = l b·i n
N· m x 0. 7 3 8 = l b·ft
N· m m x 0. 1 4 2 = o z·i n
m P a· s = c P
Di s cl ai m er
T h e i nf or m ati o n
pr o vi d e d i n t hi s
T e c h ni c al
D at a
S h e et ( T D S) i n cl u di n g t h e
r e c o m m e n d ati o n s f or
u s e
a n d
a p pli c ati o n
of t h e
pr o d u ct
ar e
b a s e d
o n
o ur
k n o wl e d g e a n d e x p eri e n c e of t h e pr o d u ct a s at t h e d at e of t hi s T D S. T h e pr o d u ct
c a n h a v e a v ari et y of diff er e nt a p pli c ati o n s a s
w ell a s diff eri n g a p pli c ati o n a n d
w or ki n g c o n diti o n s i n y o ur e n vir o n m e nt t h at ar e b e y o n d o ur c o ntr ol.
H e n k el i s,
t h er ef or e, n ot li a bl e f or t h e s uit a bilit y of o ur pr o d u ct f or t h e pr o d u cti o n pr o c e s s e s
a n d c o n diti o n s i n r e s p e ct
of
w hi c h y o u
u s e t h e m,
a s
w ell
a s t h e i nt e n d e d
a p pli c ati o n s a n d r e s ult s.
W e str o n gl y r e c o m m e n d t h at y o u c arr y o ut y o ur o w n
pri or tri al s t o c o nfir m s u c h s uit a bilit y of o ur pr o d u ct. A n y li a bilit y i n r e s p e ct of t h e
i nf or m ati o n i n t h e T e c h ni c al  
D at a S h e et or a n y ot h er  
writt e n or or al
r e c o m m e n d ati o n( s) r e g ar di n g t h e
c o n c er n e d
pr o d u ct i s
e x cl u d e d,
e x c e pt if
ot h er wi s e e x pli citl y a gr e e d a n d e x c e pt i n r el ati o n t o d e at h or p er s o n al i nj ur y
c a u s e d
b y
o ur
n e gli g e n c e
a n d
a n y li a bilit y
u n d er
a n y
a p pli c a bl e
m a n d at or y
pr o d u ct li a bilit y l a w.
I n c a s e pr o d u ct s ar e d eli v er e d b y
H e n k el
B el gi u m
N V,
H e n k el
El e ctr o ni c
M at eri al s N V, H e n k el N e d erl a n d B V, H e n k el T e c h n ol o gi e s Fr a n c e S A S a n d
H e n k el Fr a n c e S A pl e a s e a d diti o n all y n ot e t h e f oll o wi n g:
I n c a s e
H e n k el
w o ul d b e n e v ert h el e s s h el d li a bl e, o n
w h at e v er l e g al gr o u n d,
H e n k el’ s li a bilit y will i n n o e v e nt e x c e e d t h e a m o u nt of t h e c o n c er n e d d eli v er y.
I n c a s e pr o d u ct s ar e d eli v er e d b y H e n k el C ol o m bi a n a, S. A. S. t h e f oll o wi n g
di s cl ai m er i s a p pli c a bl e:
T h e i nf or m ati o n
pr o vi d e d i n t hi s
T e c h ni c al
D at a
S h e et ( T D S) i n cl u di n g t h e
r e c o m m e n d ati o n s f or
u s e
a n d
a p pli c ati o n
of t h e
pr o d u ct
ar e
b a s e d
o n
o ur
k n o wl e d g e a n d e x p eri e n c e of t h e pr o d u ct a s at t h e d at e of t hi s T D S. H e n k el i s,
t h er ef or e, n ot li a bl e f or t h e s uit a bilit y of o ur pr o d u ct f or t h e pr o d u cti o n pr o c e s s e s
a n d c o n diti o n s i n r e s p e ct
of
w hi c h y o u
u s e t h e m,
a s
w ell
a s t h e i nt e n d e d
a p pli c ati o n s a n d r e s ult s.
W e str o n gl y r e c o m m e n d t h at y o u c arr y o ut y o ur o w n
pri or tri al s t o c o nfir m s u c h s uit a bilit y of o ur pr o d u ct.
A n y li a bilit y i n r e s p e ct of t h e i nf or m ati o n i n t h e T e c h ni c al D at a S h e et or a n y ot h er
writt e n or or al r e c o m m e n d ati o n( s) r e g ar di n g t h e c o n c er n e d pr o d u ct i s e x cl u d e d,
e x c e pt if ot h er wi s e e x pli citl y a gr e e d a n d e x c e pt i n r el ati o n t o d e at h or p er s o n al
i nj ur y c a u s e d b y o ur n e gli g e n c e a n d a n y li a bilit y u n d er a n y a p pli c a bl e
m a n d at or y
pr o d u ct li a bilit y l a w.
I n c a s e pr o d u ct s ar e d eli v er e d b y
H e n k el
C or p or ati o n, or
H e n k el
C a n a d a
C or p or ati o n, t h e f oll o wi n g di s cl ai m er i s a p pli c a bl e:
T h e d at a c o nt ai n e d h er ei n ar e f ur ni s h e d f or i nf or m ati o n o nl y a n d ar e b eli e v e d t o
b e r eli a bl e.
W e c a n n ot a s s u m e r e s p o n si bilit y f or t h e r e s ult s o bt ai n e d b y ot h er s
o v er
w h o s e
m et h o d s
w e
h a v e
n o
c o ntr ol. It i s t h e
u s er' s r e s p o n si bilit y t o
d et er mi n e s uit a bilit y f or t h e u s er' s p ur p o s e of a n y pr o d u cti o n
m et h o d s
m e nti o n e d
h er ei n a n d t o a d o pt s u c h pr e c a uti o n s a s
m a y b e a d vi s a bl e f or t h e pr ot e cti o n of
pr o p ert y a n d of p er s o n s a g ai n st a n y h a z ar d s t h at
m a y b e i n v ol v e d i n t h e h a n dli n g
a n d
u s e t h er e of. I n li g ht
of t h e f or e g oi n g,
H e n k el
C or p or ati o n
s p e cifi c all y
di s cl ai m s
all
w arr a nti e s
e x pr e s s e d
or i m pli e d, i n cl u di n g
w arr a nti e s
of
m er c h a nt a bilit y or fit n e s s f or a p arti c ul ar p ur p o s e, ari si n g fr o m s al e or u s e
of  
H e n k el  
C or p or ati o n’ s 
pr o d u ct s.  
H e n k el  
C or p or ati o n 
s p e cifi c all y
di s cl ai m s a n y li a bilit y f or c o n s e q u e nti al or i n ci d e nt al d a m a g e s of a n y ki n d,
i n cl u di n g l o st pr ofit s.
T h e di s c u s si o n h er ei n of v ari o u s pr o c e s s e s or
c o m p o siti o n s i s n ot t o b e i nt er pr et e d a s r e pr e s e nt ati o n t h at t h e y ar e fr e e fr o m
d o mi n ati o n
of
p at e nt s
o w n e d
b y
ot h er s
or
a s
a li c e n s e
u n d er
a n y
H e n k el
C or p or ati o n
p at e nt s t h at
m a y
c o v er
s u c h
pr o c e s s e s or c o m p o siti o n s.  W e
r e c o m m e n d t h at
e a c h
pr o s p e cti v e
u s er t e st
hi s
pr o p o s e d
a p pli c ati o n
b ef or e
r e p etiti v e u s e, u si n g t hi s d at a a s a g ui d e. T hi s pr o d u ct
m a y b e c o v er e d b y o n e or
m or e U nit e d St at e s or f or ei g n p at e nt s or p at e nt a p pli c ati o n s.
Tr a d e m ar k u s a g e
E x c e pt a s ot h er wi s e n ot e d, all tr a d e m ar k s i n t hi s d o c u m e nt ar e tr a d e m ar k s of
H e n k el C or p or ati o n i n t h e U. S. a n d el s e w h er e. ® d e n ot e s a tr a d e m ar k r e gi st er e d
i n t h e U. S. P at e nt a n d Tr a d e m ar k Offi c e.
R ef er e n c e 1. 4
F or t h e
m o st dir e ct a c c e s s t o l o c al s al e s a n d t e c h ni c al s u p p ort vi sit: w w w. h e n k el. c o m/i n d u stri al

5 3  
 
 
 
 
 
 
 
 
 
A p pe n di x C : PI c urric ul u m vit ae  
 
 
 
 

C urric ul u m Vit ae 
K EI T H L. O B S T EI N, M D, M P H, F A S G E , F A C G, A G A F 
Office A d dress: 
1 3 0 1 Me dical Ce nter Dri ve; 1 6 6 0 T V C 
 
Nas h ville, T N 3 7 2 3 2 
Office P h o ne N u m ber:  
6 1 5- 3 2 2- 0 1 2 8 
 
M o bile P h o ne: 
2 1 5- 9 0 1- 9 6 6 1 
 
 
E d uc ati o n:  
T he J o h ns H o p ki ns U ni versit y, Balti m ore, M D, B. S. Bi o me dical E n gi neeri n g ( Materials Scie nce 
a n d E n gi neeri n g c o nce ntrati o n), 1 9 9 6 – 2 0 0 0 
 
N ort h wester n U ni versit y Fei n ber g Sc h o ol of Me dici ne, C hica g o, I L, M. D., 2 0 0 0 – 2 0 0 4 
 
H os pital of T he U ni versit y of Pe n ns yl va nia,  P hila del p hia, P A, T he U ni versit y of Pe n ns yl va nia 
Sc h o ol of Me dici ne , I nter ns hi p i n I nter nal Me dici ne ( 2 0 0 4- 2 0 0 5).  Resi de nc y i n I nter nal 
Me dici ne ( 2 0 0 5- 2 0 0 7) 
 
Bri g ha m a n d W o me n’s H os pital, B ost o n, M A, Har var d Me dical Sc h o ol, Fell o ws hi p i n 
Gastr oe nter ol o g y, 2 0 0 7 – 2 0 1 0 
 
Har var d U ni versit y Sc h o ol of P u blic Healt h, B ost o n, M A, M. P. H. ( 2 0 0 9- 2 0 1 0); Pr o gra m i n 
Cli nical Effecti ve ness ( 2 0 0 8) 
 
 
Lice ns ure a n d Certific ati o n:  
Me dical Trai ni n g Lice nse, C o m m o n wealt h of Pe n ns yl va nia, N u m ber M T- 1 8 3 7 9 3; I nacti ve; 
Ori gi nal date 0 6/ 2 0 0 4; E x pirati o n date 0 6/ 2 0 0 7 
 
Me dical Trai ni n g Lice nse, C o m m o n wealt h of Massac h usetts, N u m ber 2 3 1 9 2 7; I nacti ve; Ori gi nal 
date 0 7/ 0 1/ 2 0 0 7; E x pirati o n date 0 6/ 3 0/ 2 0 1 0 
 
B oar d Certifie d I nter nal Me dici ne, A merica n B oar d of I nter nal Me dici ne,  N u m ber 2 8 3 5 7 8; 
Ori gi nal date 0 8/ 2 4/ 2 0 0 7; E x pirati o n date 1 2/ 3 1/ 2 0 1 7 
 
Me dical Lice nse, State of Te n nessee , N u m ber 4 6 2 4 6; Acti ve; Ori gi nal date 0 5/ 1 9/ 2 0 1 0; 
E x pirati o n date 1 0/ 3 1/ 2 0 2 2 
 
B oar d Certifie d Gastr oe nter ol o g y, A merica n B oar d of I nter nal Me dici ne, N u m ber 2 8 3 5 7 8; 
Acti ve; Ori gi nal date 1 1/ 1 4/ 2 0 1 1; E x pirati o n date 1 2/ 3 1/ 2 0 2 2 
 
 
 
 

2 
 
Ac a de mic A p p oi nt me nts: 
Va n der bilt U ni versit y Me dical Ce nter, Nas h ville, T N, Pr ofess or of Me dici ne, Va n der bilt 
U ni versit y Sc h o ol of Me dici ne, Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, 
0 1/ 2 0 2 2 - Prese nt 
 
Va n der bilt U ni versit y, Nas h ville, T N, Ass ociate Pr ofess or of Mec ha nical E n gi neeri n g, 
Va n der bilt U ni versit y Sc h o ol of E n gi neeri n g, De part me nt of Mec ha nical E n gi neeri n g, 0 7/ 2 0 1 5 - 
Prese nt  
 
Va n der bilt U ni versit y Me dical Ce nter, Nas h ville, T N, Ass ociate Pr ofess or of Me dici ne, 
Va n der bilt U ni versit y Sc h o ol of Me dici ne, Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d 
N utriti o n, 0 7/ 2 0 1 5 - 1 2/ 2 0 2 1 
 
Va n der bilt U ni versit y, Nas h ville, T N, Assista nt Pr ofess or of Mec ha nical E n gi neeri n g, 
Va n der bilt U ni versit y Sc h o ol of E n gi neeri n g, De part me nt of Mec ha nical E n gi neeri n g, 2 0 1 2 - 
2 0 1 5  
 
Va n der bilt U ni versit y Me dical Ce nter, Nas h ville, T N, Assista nt Pr ofess or of Me dici ne, 
Va n der bilt U ni versit y Sc h o ol of Me dici ne, Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d 
N utriti o n, 0 7/ 2 0 1 0 - 0 6/ 2 0 1 5 
 
 
Pr ofessi o n al Or g a niz ati o ns: 
A merica n S ociet y f or Bi oet hics a n d H u ma nities ( 2 0 0 4) 
 
A merica n Gastr oe nter ol o gical Ass ociati o n ( 2 0 0 7) 
 
A merica n S ociet y f or Gastr oi ntesti nal E n d osc o p y ( 2 0 1 0)  
 
Va n der bilt I nstit ute i n S ur ger y a n d E n gi neeri n g ( 2 0 1 1) 
 
A merica n C olle ge of Gastr oe nter ol o g y ( 2 0 1 1) 
 
 
Pr ofessi o n al Acti vities: 
J o h ns H o p ki ns U ni versit y Office of U n der gr a d u ate A d missi o ns 
Al u m ni A d missi o ns Re prese nt ative, 2 0 0 0 – Prese nt 
 
N ort h wester n U ni versit y Fei n ber g Sc h o ol of Me dici ne – Office of A d missi o ns 
Me dic al Sc h o ol A d missi o ns C o m mittee Me m ber ( 2 0 0 3- 2 0 0 4). 
T o ur G ui de a n d P a nel Disc ussi o n P artici p a nt ( 2 0 0 0- 2 0 0 3).  
R ole i ncl u de d re vie wi n g a p plica nts t o i de ntif y s uita ble ca n di dates a n d t o rec o m me n d a d missi o n 
of t h ose ca n di dates i nt o t he me dical sc h o ol, 2 0 0 0 - 2 0 0 4 
 
H os pit al of t he U ni versit y of Pe n ns yl v a ni a Et hics C o m mittee  
Et hics C o m mittee Me m ber, H o usest aff Re prese nt ative .   
Me m ber of t he Et hics C o m mittee partici pati n g i n c o ns ults, meeti n gs, e d ucati o n, a n d p olic y 
f or mati o n, 2 0 0 4 - 2 0 0 6 

3 
 
 
T he J o ur n al of Cli nic al Et hics   
I nvite d Peer- Revie wer, 2 0 0 5 – 2 0 1 0 
 
Bri g h a m a n d W o me n’s H os pit al, Di visi o n of G astr oe nter ol o g y, E d uc ati o n C o m mittee 
Fell o w Re prese nt ative, 2 0 0 8 – 2 0 1 0 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
Me m ber, Tr ai ni n g C o m mittee, 2 0 1 2- 2 0 1 5 
De vel o p resi de nc y a n d fell o ws hi p pr o gra m g ui deli nes f or trai ni n g i n e n d osc o p y a n d relate d 
pr oce d ures.  De vel o p p olic y a n d rec o m me n dati o ns f or t he S ociet y’s r ole o n be half of 
gastr oi ntesti nal e n d osc o p y i n its relati o ns wit h Direct ors of resi de nc y trai ni n g pr o gra ms a n d 
certif yi n g or ga nizati o ns.  C o or di nati o n of t he First- Year Fell o ws E n d osc o p y Trai ni n g C o urse.  
De vel o p me nt of trai ni n g m o d ules o n A S G E we bsite.  Pla n a n d e val uate t he a n n ual Trai ni n g 
Direct ors W or ks h o p a n d de vel o p trai ni n g re q uire me nts i n all as pects of ne w a n d a d va nce d 
e n d osc o pic s kills.  De vel o p te m plates f or e d ucati o nal pr o gra ms i n e n d osc o p y f or Trai ni n g 
Pr o gra m Direct ors.  Trac k tre n ds a n d statistics i n Gastr oe nter ol o g y trai ni n g pr o gra ms. 
 
A meric a n C olle ge of G astr oe nter ol o g y ( A C G) 
Me m ber, P u blic Rel ati o ns C o m mittee, 2 0 1 2 – 2 0 1 8   
I ncrease t he visi bilit y of t he A C G t o t he ge neral p u blic t hr o u g h ke y c o m m u nicati o ns c ha n nels: 
ra di o, tele visi o n, pri nt, vi de o, I nter net a n d patie nt e d ucati o n materials.  Ser ve t he p u blic a n d 
ge neral press as t he a ut h orit y o n cli nical GI a n d li ver iss ues.   Stri ve t o ear n rec o g niti o n f or 
A C G’s a d v ocac y f or patie nt healt h care be nefits, e. g., c ol orectal ca ncer scree ni n g.   C o n d uct 
me dia o utreac h s urr o u n di n g t he A n n ual Scie ntific Meeti n g t o pr o m ote ne w researc h fi n di n gs a n d 
a d va nces i n cli nical gastr oe nter ol o g y. 
 
A meric a n C olle ge of G astr oe nter ol o g y ( A C G) E d uc ati o n al Aff airs A n n u al Meeti n g 
A bstr act Re vie w S u bc o m mittee 
Me m ber, St o m ac h Secti o n  2 0 1 4 
C h air, St o m ac h Secti o n 2 0 1 5 
Me m ber, Cli nic al Vi g nettes Secti o n 2 0 1 7 
Me m ber, Cli nic al Vi g nettes Secti o n 2 0 2 0 
 
E n d osc o p y ( J o ur n al) 
I nvite d Peer - Revie wer, 2 0 1 4 – Prese nt 
 
G astr oe nter ol o g y ( J o ur n al) 
I nvite d Peer- Revie wer, 2 0 1 4 – Prese nt 
S peci al Secti o n E dit or: C o nti n ui n g Me dic al E d uc ati o n ( C M E), 2 0 1 6 - Prese nt 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E)  
Me m ber, E n d osc o pist- i n- Resi de nce ( EI R) T ask F orce, 2 0 1 4 – 2 0 1 7 
Me m ber, Me m ber E n g a ge me nt a n d Diversity C o m mittee, 2 0 1 6 – 2 0 1 9 
Me m ber, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) Pr o gr a m T ask F orce, 2 0 1 5 – 2 0 1 9 
Me m ber, E- Le ar ni n g C o m mittee, 2 0 1 9 – 2 0 2 1 

4 
 
Me m ber, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) Pr o gr a m C o m mittee, 2 0 2 0 – Prese nt 
Me m ber, GI a n d A dv a nce d E n d osc o py Fell o ws ( GI A E F) Tr ai ni n g W ork Gr o u p, 2 0 2 1 – Prese nt 
Me m ber, E d uc ati o n C urric ul u m a n d C o m pete ncies C o u ncil ( E C C C), 2 0 2 1 – Prese nt 
 
 
 
V a n der bilt U ni versit y Me dic al Ce nter 
Pr o gr a m Direct or, G astr oe nter ol o gy Fell o ws hi p Tr ai ni n g Pr o gr a m, 2 0 1 5 – Prese nt 
Direct or, C o nti n ui n g Me dic al E d uc ati o n ( C M E) G astr oe nter ol o gy Divisi o n, 2 0 1 5 – Prese nt 
G astr oe nter ol o gy – E mer ge ncy De p art me nt Li ais o n, 2 0 1 7 – Prese nt 
De p art me nt of Me dici ne Well ness T ask F orce, GI Secti o n C h air, 2 0 2 0 – Prese nt 
P artici p a nt, Mi d- C areer Le a ders hi p Devel o p me nt Pr o gr a m, 2 0 1 7 
Ass oci ate Pr o gr a m Direct or, G astr oe nter ol o gy Fell o ws hi p Tr ai ni n g Pr o gr a m, 2 0 1 3 – 2 0 1 5 
 
Alli a nce f or Ac a de mic I nter n al Me dici ne ( A AI M) 
Ass oci ati o n of S peci alty Pr ofess ors ( A S P) C o u ncil Me m ber, 2 0 1 7 – Prese nt 
A S P Li ais o n t o t he A AI M Rese arc h C o m mittee, 2 0 1 8 – 2 0 2 0 
T he A AI M is a nati o nal or ga nizati o n t hat f osters t he a d va nce me nt of lear ni n g, disc o ver y, a n d 
cari n g b y e n ha nci n g t he pr ofessi o nal gr o wt h of aca de mic i nter nal me dici ne fac ult y, 
a d mi nistrat ors, a n d p h ysicia ns- i n-trai ni n g.  I ser ve as a c o u ncil me m ber i n t he lea ders hi p 
str uct ure of t he or ga nizati o n a n d re prese nt t he Gastr oe nter ol o g y s ocieties.  I a m als o t he liais o n 
f or A S P t o t he A AI M researc h c o m mittee. 
 
Vir g o 
Me m ber, Me dic al A dvis ory B o ar d,  2 0 1 7 – Prese nt 
Me dical a n d s ur gical s ol uti o ns c o m pa n y t hat s pecializes i n a ut o mate d me dical vi de o ca pt ure. 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E)/ T o uc h S ur ger y  
Dellert E a n d O bstei n K L; P oly pect o my: j u m b o c ol d bi o psy f orce ps, c ol d s n are, a n d s n are 
c a utery f or T o uc h S ur gery m o bile a p plic ati o n 
T o uc h S ur ger y is t he m ost d o w nl oa de d a p p- base d s ur gical si m ulati o n platf or m gl o ball y, 
deli veri n g si m ulati o n c o nte nt t o 2. 5 milli o n s ur ge o ns a n d healt hcare pr o vi ders ar o u n d t he w orl d.  
T he si m ulati o n li brar y f or p ol y pect o m y is b uilt t hr o u g h acti ve c olla b orati o n wit h t he A S G E t o 
pr o vi de i nteracti ve A p p- base d si m ulati o n t o lear n, si m ulate, re hearse, a n d test s ur gical 
s kills/tec h ni q ues. 
 
N ati o n al I m a ge- G ui de d T her a p y (I G T) W or ks h o p 2 0 1 8 
Sessi o n 4: R o b otic S ur gery, S ur gic al Tr ai ni n g, T her a py Delivery C o- C h air, Oct o ber 2 0 1 8 
( B ost o n, M A) 
T he Nati o nal I G T W or ks h o p is s p o ns ore d b y t he Nati o nal I nstit utes of Healt h ( NI H) t o f oster 
disc o urse i n tra nslati o nal researc h i n i ma ge- g ui de d t hera p y i n t he NI H f u n de d c o m m u nit y a n d t o 
c o m m u nicate t he a vaila bilit y of t he Nati o nal Ce nter f or I ma ge G ui de d T hera p y as a nati o nal 
res o urce f or t o ols a n d tec h n ol o gies i n t he fiel d.  Atte n dees i ncl u de NI H f u n de d aca de mic 
scie ntists, cli nicia ns, a n d lea ders fr o m i n d ustr y a n d fe deral a ge ncies i ntereste d i n i ma ge- g ui de d 
i nter ve nti o ns. 
 
Accre dit ati o n C o u ncil f or Gr a d u ate Me dic al E d uc ati o n ( A C G M E) 

5 
 
Milest o nes 2. 0: G astr oe nter ol o gy Milest o nes, C o m mittee Me m ber, 2 0 1 9- Prese nt 
T he A C G M E is  t he b o d y res p o nsi ble f or accre diti n g t he maj orit y of gra d uate me dical trai ni n g 
pr o gra ms f or p h ysicia ns i n t he U nite d States.  It is a n o n- pr ofit pri vate c o u ncil t hat e val uates a n d 
accre dits me dical resi de nc y a n d i nter ns hi p pr o gra ms.  I ser ve as a me m ber of t he 
Gastr oe nter ol o g y Milest o nes w or k- gr o u p/c o m mittee. 
 
A meric a n G astr oe nter ol o gic al Ass oci ati o n ( A G A) 
Me m ber, G astr oe nter ol o gy Tr ai ni n g Ex a mi n ati o n ( G T E) C o m mittee, 2 0 1 9- Prese nt  
T he A G A G T E C o m mittee is res p o nsi ble f or t he creati o n, re visi o n, a nal ysis, a n d a d mi nistrati o n 
of t he a n n ual e xa mi nati o n t hat is ta ke n b y Gastr oe nter ol o g y trai nees acr oss t he w orl d.  I ser ve as 
a me m ber of t he c o m mittee wit h s pecial f oc us o n t he secti o ns of ge neral gastr oe nter ol o g y a n d 
s mall b o wel. 
 
V a n der bilt U ni versit y Me dic al Ce nter, De p art me nt of I nter n al Me dici ne, Well ness 
C o m mittee 
Me m ber, 2 0 2 0 – Prese nt.    
T he De part me nt of I nter nal Me dici ne at V U M C, u n der t he directi o n of t he C hair of Me dici ne, 
has esta blis he d a Well ness C o m mittee t o facilitate c o m m u nit y b uil di n g, e n ga ge me nt wit h t he 
i nstit uti o n a n d de part me nt, a n d f oster a c o m m u nit y of ki n d ness, e nc o ura ge me nt, a n d s u p p ort f or 
fac ult y, trai nees, a n d staff at V U M C.  
 
Ne pt u ne Me dic al 
C o ns ult a nt, 2 0 2 1.  
Me dical a n d s ur gical s ol uti o ns c o m pa n y t hat s pecializes s ur gical/e n d osc o pic de vices. 
 
V a n der bilt U ni versit y: Desti n ati o n V a n der bilt — C o m p uter Scie nce 
C o m p uter Scie nce F ac ulty Se arc h C o m mittee Me m ber, 2 0 2 1 – Prese nt.    
Va n der bilt U ni versit y has esta blis he d t he g oal of d o u bli n g t he fac ult y of t he De part me nt of 
C o m p uter Scie nce.  U n der t he directi o n of t he C hair of C o m p uter Scie nce, I ser ve as a me m ber 
of t his c o m mittee t o create a p o ol a n d hire tale nte d ca n di dates.  
 
V a n der bilt I nstit ute f or S ur ger y a n d E n gi neeri n g (VI S E ) Steeri n g C o m mittee  
Me m ber, 2 0 2 1 – Prese nt 
T he VI S E is a n i nter disci pli nar y I nstit ute t hat s pa ns Va n der bilt U ni versit y a n d Va n der bilt 
U ni versit y Me dical Ce nter t o facilitate a d va nce me nt of tec h n ol o gies t hr o u g h effecti ve, efficie nt, 
a n d n o vel c olla b orati o n bet wee n E n gi neers, C o m p uter Scie ntists, a n d Me dical Pr ofessi o nals.   
Ce ntral t o t he missi o n of t he i nstit ute is t he tra nslati o n of met h o ds, tec h ni q ues, a n d de vices fr o m 
t he la b orat or y t o t he patie nt, first i nter nall y t he n e xter nall y t hr o u g h c o m mercializati o n of t he 
i ntellect ual pr o pert y ce nter me m bers ha ve ge nerate d. 
 
V a n der bilt U ni versit y Sc h o ol of Me dici ne 
2 0 2 2 F ac ulty A w ar d Revie w C o m mittee Me m ber, 2 0 2 2 – Prese nt.    
Me m ber of t he a war d re vie w c o m mittee. 
 
Ac a de m y f or E xcelle nce i n E d uc ati o n – V a n der bilt U ni versit y Sc h o ol of Me dici ne 
Me m ber, 2 0 2 2 – Prese nt.    

6 
 
T he Aca de m y f or E xcelle nce i n E d ucati o n is a n or ga nizati o n t o pr o m ote, facilitate, a n d 
c ha m pi o n e xcelle nce i n t he Sc h o ol of Me dici ne e d ucati o nal e n dea v ors acr oss t he Va n der bilt 
e nter prise.  Me m bers hi p i nt o t he Aca de m y is a hi g hl y selecti ve pr ocess base d o n de m o nstrati o n 
of e d ucati o nal s kill, c urric ul u m de vel o p me nt, me nt ors hi p, m ulti-f or mat teac hi n g, a n d 
sc h olars hi p. 
 
 
H o n ors a n d A w ar ds : 
Ea gle Sc o ut – B o y Sc o uts of A merica, 1 9 9 4 
 
Ta u Beta Pi, T he Nati o nal E n gi neeri n g H o n or S ociet y, 1 9 9 8 
 
Al p ha Eta M u Beta, Nati o nal Bi o me dical E n gi neeri n g H o n or S ociet y, 1 9 9 9 
 
O micr o n Delta Ka p pa, Na ti o nal Lea ders hi p H o n or S ociet y, 1 9 9 9 
 
St u de nt E xcelle nce A war d f or Lea ders hi p a n d Ser vice , J o h ns H o p ki ns U ni versit y, 2 0 0 0 
 
S o ni x C or p orati o n A war d i n I m mersi o n Ultras o nics, 2 0 0 0 
 
N ort h wester n U ni versit y Me dical Sc h o ol M 1 I nter nati o nal Healt h Fell o ws hi p Pr o gra m, Gra nt 
Reci pie nt f or I n de pe n de nt Researc h c o n d ucte d i n A mster da m, T he Net herla n ds, 2 0 0 1 
 
N ort h wester n U ni versit y Me dical Sc h o ol M 4 I nter nati o nal Healt h Fell o ws hi p Pr o gra m, Gra nt  
Reci pie nt f or I n de pe n de nt W or k c o n d ucte d i n C hel msf or d, E n gla n d, 2 0 0 4 
 
Fell o w, A merica n S ociet y f or Gastr oi ntesti nal E n d osc o p y ( F A S G E), 2 0 1 6 
 
Ha ml y n S y m p osi u m of Me dical R o b otics S ur gical R o b ot C halle n ge O verall Wi n ner a n d Best 
A p plicati o n Prize 2 0 1 6, L o n d o n, U K, 2 0 1 6 
 
Fell o w, A merica n C olle ge of Gastr oe nter ol o g y ( F A C G), 2 0 1 7 
 
I nter nati o nal S y m p osi u m o n Me dical R o b otics, Wi n ner: Best St u de nt Pa per Prize 2 0 1 8, Atla nta, 
G A,  U S A, 2 0 1 8 
 
Fell o w, A merica n Gastr oe nter ol o gical Ass ociati o n ( A G A F), 2 0 1 9 
 
Ha ml y n S y m p osi u m of Me dical R o b otics S ur gical R o b ot C halle n ge Best Vi de o A war d 2 0 1 9, 
L o n d o n, U K, 2 0 1 9 
 
Me dica 2 0 1 9 K U K A I n n o vati o n A war d, Tea m R o b o F O R C E, D üssel d orf, Ger ma n y, 2 0 1 9 
 
Di gesti ve Disease Wee k 2 0 2 0 P oster of Disti ncti o n, C hica g o, I L, U S A, 2 0 2 0 
 
Best- of-t he- Best Vi de o A war d, A S G E Vi de o C o m petiti o n, O nli ne d ue t o C O VI D- 1 9, 2 0 2 0 
 
 

7 
 
 
Te ac hi n g Acti vities: 
P atie nt, P h ysici a n a n d S ociet y II: T he Pr ofessi o n of Me dici ne Cl ass  
G uest Lect urer 
N ort h wester n U ni versit y Me dical Sc h o ol.  G uest Lect urer o n t he t o pic of P h ysicia n Assiste d 
S uici de/ E ut ha nasia, wit h e m p hasis o n t he D utc h e x perie nce, 2 0 0 1 - 2 0 0 4  
 
E d uc ati o n f or P h ysici a ns o n E n d- of- Life C are ( T he E P E C Pr oject) 
E P E C Tr ai ner –I nstr uct or  
A R o bert W o o d J o h ns o n F o u n dati o n s u p p orte d pr o gra m t hat trai ns healt hcare pr o vi ders t o 
bec o me teac hers of t he c ore c o m pete ncies of palliati ve care.  C urre ntl y t here are a p pr o xi matel y 
1 4 0 0 certifie d E P E C trai ners, 2 0 0 3 – 2 0 0 7 
 
T he U niversity of Pe n nsylv a ni a Sc h o ol of Me dici ne, De p art me nt of Me dici ne, H o usest aff 
Steeri n g C o m mittee 
I nter n Cl ass Re prese nt ative ( 2 0 0 4- 0 5) 
Resi de nt Cl ass Re prese nt ative ( 2 0 0 5- 2 0 0 7) 
Electe d re prese ntati ve of t he De part me nt of Me dici ne H o usestaff t o t he Resi de nc y Pr o gra m 
 
H os pit al of t he U ni versit y of Pe n ns yl v a ni a Et hics C o m mittee    
  
 
Et hics C o m mittee Me m ber, H o usest aff Re prese nt ative. 
Me m ber of t he Et hics C o m mittee partici pati n g i n c o ns ults, meeti n gs, e d ucati o n, a n d p olic y 
f or mati o n, 2 0 0 6 - 2 0 0 7 
 
P atie nt D oct or II C o urse: T he A b d o mi n al E x a m 
F ac ulty, H arv ar d Me dic al Sc h o ol.  
Teac hi n g sec o n d- year me dical st u de nts e xa mi nati o n of t he a b d o me n, 2 0 0 8- 2 0 1 0 
 
I ntr o d ucti o n t o Cli nic al Me dici ne 
F ac ulty, H arv ar d Me dic al Sc h o ol 
Teac hi n g M D/ P h D st u de nts hist or y ta ki n g a n d p h ysical e xa mi nati o n s kills.  Prece pt or f or patie nt 
e nc o u nters i n t he h os pital.  Re vie wer of st u de nts’ writte n H & P’s, 2 0 1 0 
 
I nter n al Me dici ne Resi de nc y Di d actic C urric ul u m C o m mittee 
G astr oe nter ol o gy F ac ulty Re prese nt ative, V a n der bilt U niversity Me dic al Sc h o ol 
Assist wit h t he selecti o n a n d pri oritizati o n of a p pr o priate c urric ul u m t o pics f or i nter ns a n d 
resi de nts.  Facilitate fac ult y prese nters f or eac h t o pic.  I de ntif y fac ult y f or n o n-lect ure f or mat 
sessi o ns.  Or ga nize a n d facilitate t he e d ucati o nal c urric ul u m, 2 0 1 0 – 2 0 1 5 
 
Prece pt ors hi p i n Cli nic al Me dici ne  
Prece pt or, V a n der bilt U niversity Sc h o ol of Me dici ne 
Prece pt or f or patie nt e nc o u nters i n t he o ut patie nt setti n g f or t w o first- year me dical st u de nts, 2 0 1 1 
- Prese nt 
 
P atie nt, Pr ofessi o n, a n d S ociet y II ( P P S II) 
F ac ulty, V a n der bilt U niversity Me dic al Sc h o ol 

8 
 
Teac hi n g sec o n d- year me dical st u de nts basic e pi de mi ol o g y, bi ostatistics, a n d literat ure re vie w 
tec h ni q ues ar o u n d critical cli nical, s ocial, c ult ural, a n d i nter pers o nal iss ues ass ociate d wit h t he 
practice of me dici ne, 2 0 1 2 – 2 0 1 5 
 
E n d osc o p y C ore C urric ul u m 
C o- Direct or ( 2 0 1 2- 2 0 2 0), Direct or ( 2 0 2 0- Prese nt), V a n der bilt U niversity Me dic al Ce nter, 
Divisi o n of G astr oe nter ol o gy, He p at ol o gy a n d N utriti o n.    
E n d osc o p y e d ucati o n c o urse f or all Gastr oe nter ol o g y Fell o ws at Va n der bilt U ni versit y.  Feat ures 
a series of di dactic a n d ha n ds- o n e x perie nces, 2 0 1 2 – Prese nt 
 
I nter n al Me dici ne Resi de nc y J o ur n al Cl u b  
I nvite d Cli nic al Ex pert, G astr oe nter ol o gy, V a n der bilt U niversity Me dic al Ce nter 
Pr o vi de cli nical bac k gr o u n d a n d e x pertise f or ma n uscri pts t hat are re vie we d/ disc usse d wit hi n t he 
fiel d of Gastr oe nter ol o g y, 2 0 1 2 – Prese nt 
 
A meric a n C olle ge of G astr oe nter ol o g y ( A C G) S o ut he ast Re gi o n al C o urse 
F ac ulty, H a n ds- O n Sessi o n, 2 0 1 3 
F ac ulty, H a n ds- O n Sessi o n, 2 0 1 5 
F ac ulty, H a n ds- O n Sessi o n, 2 0 1 6 
F ac ulty, H a n ds- O n Sessi o n, 2 0 1 7 
 
V a n der bilt U ni versit y G astr oe nter ol o g y Fell o ws hi p Pr o gr a m  
Pr o gr a m Direct or, 2 0 1 5 - Prese nt  
Ass oci ate Pr o gr a m Direct or,  2 0 1 3 - 2 0 1 5 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
C o- Direct or, First Ye ar Fell o ws C o urse, 2 0 1 3, 2 0 1 4, 2 0 1 5 
F ac ulty, First Ye ar Fell o ws C o urse, 2 0 1 7 
A n n ual e n d osc o p y c o urse f or first year Gastr oe nter ol o g y fell o ws t hat i ncl u des b ot h dia datic 
prese ntati o ns a n d ha n ds- o n e x perie nce.  T he c o urse ta kes place at t he A S G E’s I nstit ute f or 
Trai ni n g a n d Tec h n ol o g y (I T & T) i n D o w ners Gr o ve, I L. 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
F ac ulty, Se ni or Fell o ws C o urse , 2 0 1 5 
A n n ual e n d osc o p y c o urse f or sec o n d- a n d t hir d- year Gastr oe nter ol o g y fell o ws t hat i ncl u des b ot h 
di dactic prese ntati o ns a n d ha n ds- o n e x perie nce.  T he c o urse ta kes place at Di gesti ve Disease 
Wee k t he a n n ual Gastr oe nter ol o g y meeti n g of t he A G A, A S G E, A A S L D, a n d S S A T. 
 
V a n der bilt U ni versit y Di visi o n of G astr oe nter ol o g y, He p at ol o g y a n d N utriti o n  
C M E Activity Direct or,  2 0 1 5 – Prese nt 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
F ac ulty, L o wer- E M R Skills Tr ai ni n g Assess me nt Rei nf orce me nt ( S T A R) Certific ate Pr o gr a m , 
2 0 1 7, 2 0 1 9, 2 0 2 0 
T he A S G E S T A R  Certificate Pr o gra m is a n assess me nt- base d c urric ul u m t hat pre pares 
e n d osc o pists t o o verc o me c halle n ges, gai n c o nfi de nce a n d de m o nstrate t heir "rea di ness" t o 
perf or m a d va nce d tec h ni q ues t o me dical c ollea g ues.  T his c o urse f oc use d o n L o wer- E M R. 
 

9 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
C o- Direct or, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) C o urse, 1 1/ 0 9/ 2 0 1 5 
Direct or, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) C o urse, 0 4/ 1 0/ 2 0 1 7 
F ac ulty, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) C o urse, 0 4/ 0 9/ 2 0 1 8 
Direct or, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) Ex act Scie nce C o urse, 0 9/ 0 9/ 2 0 1 9 
Direct or, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) C o urse, 1 1/ 0 3/ 2 0 1 9 
Di rect or, A S G E Rec o g nize d I n d ustry Associ ate ( A RI A) Re ge ner o n C o urse, 0 6/ 2 8- 0 6/ 2 9/ 2 0 2 2 
Direct or, A S G E Rec o g nize d I n d ustry Ass oci ate ( A RI A) Ir o n w o o d C o urse, D ate T B D ( C O VI D) 
T he A RI A c o urse is a Gastr oe nter ol o g y t o pic- base d e d ucati o nal pr o gra m f or i n d ustr y 
re prese ntati ves t o kee p t he m u p-t o- date o n rele va nt gastr oe nter ol o g y a n d e n d osc o pic t o pics.  T he 
c o urse ta kes place at t he A S G E’s I nstit ute f or Trai ni n g a n d Tec h n ol o g y (I T & T) i n D o w ners 
Gr o ve, I L a n d i ncl u des di dactics, q uesti o n a n d a ns wer series, a n d a ha n ds- o n sessi o n.   
 
A meric a n G astr oe nter ol o gic al Ass oci ati o n ( A G A) 
F ac ulty, Tr ai ni n g Direct ors’ W orks h o p , 2 0 1 7 
T he bie n nial w or ks h o p f or all Gastr oe nter ol o g y fell o ws hi p pr o gra m direct ors, ass ociate/assista nt 
pr o gra m direct ors, a n d pr o gra m c o or di nat ors/a d mi nistrat ors t hat is c o-s p o ns ore d b y t he A G A 
I nstit ute, A merica n C olle ge of Gastr oe nter ol o g y, A merica n Ass ociati o n f or t he St u d y of Li ver 
Diseases a n d t he A merica n S ociet y f or Gastr oi ntesti nal E n d osc o p y. 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
F ac ulty, E M R Skills Tr ai ni n g Sessi o n , 2 0 1 7 
Ha n ds- o n trai ni n g sessi o n hel d at Di gesti ve Disease Wee k 2 0 1 7 i n C hica g o, I L f or t h ose 
partici pati n g i n t he A S G E p ost- gra d uate c o urse. 
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
F ac ulty, C ol o n osc o py: Di a g n ostic t o T her a pe utic C o urse , 2 0 1 8 
C ol o n osc o p y c o urse f or p h ysicia ns.  T he c o urse ta kes place at t he A S G E’s I nstit ute f or Trai ni n g 
a n d Tec h n ol o g y (I T & T) i n D o w ners Gr o ve, I L a n d i ncl u des di dactics, q uesti o n a n d a ns wer 
series, a n d a ha n ds- o n sessi o n.  
 
A meric a n S ociet y f or G astr oi ntesti n al E n d osc o p y ( A S G E) 
F ac ulty, GI Or g a niz ati o n al Le a ders hi p Devel o p me nt ( G O L D) Pr o gr a m , 2 0 1 9 
G O L D is a 1 2- m o nt h pr o gra m offeri n g gastr oe nter ol o gists a n o p p ort u nit y t o de vel o p a n d 
e n ha nce lea ders hi p a n d career de vel o p me nt s kills t hr o u g h e d ucati o n, c oac hi n g, a n d b uil di n g 
pr ofessi o nal net w or ks.  T he p ur p ose of t he G O L D pr o gra m is t o pr o vi de t he k n o wle d ge a n d 
s kills nee de d t o e n ha nce t he pat h t o lea ders hi p wit hi n aca de mic or pri vate practice me dici ne a n d 
wit hi n A S G E. 
 
E X Celle nce I n Cli nic al T E ac hi n g ( E X CI T E) Pr o gr a m 
C o ac h, V a n der bilt U niversity Me dic al Ce nter ( V U M C), Divisi o n of I nter n al Me dici ne, 2 0 1 9 – 
Prese nt    
T he E X CI T E Pr o gra m is a l o n git u di nal c urric ul u m a n d e x perie ntial lear ni n g o p p ort u nit y f or 
I nter nal Me dici ne Resi de nts at V U M C t o gai n f o u n dati o nal k n o wle d ge a n d s kills relate d t o 
teac hi n g as a c o m ple me nt t o t heir pr ofessi o nal de vel o p me nt. 
 
 
 
 

1 0  
 
Rese arc h S u per visi o n: 
Ela n A hr o n o vic h, M S ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h c o-a d vis or, 2 0 2 1 - Prese nt 
 
Cla u di o T o m bazzi, M D (I nter nal Me dical Resi de nt) 
R ole:  Researc h me nt or, 2 0 2 0 - Prese nt 
 
Claire La n de wee ( U n der gra d uate St u de nt) 
R ole: Pri mar y researc h me nt or, 2 0 1 9 - Prese nt 
 
Ga briel Sa n d o val, M D (I nter nal Me dical Resi de nt) 
R ole:  Pri mar y researc h me nt or, 2 0 1 9 - Prese nt 
 
Cat heri ne H o we, M D ( Gastr oe nter ol o g y Fell o w) 
R ole:  Pri mar y researc h me nt or, 2 0 1 9 - 2 0 2 1 
 
Sai Raja g o pala n, P h D ( Va n der bilt U ni versit y Sc h o ol of Me dici ne Me dical St u de nt) 
R ole: Pri mar y researc h me nt or, 2 0 1 8 - 2 0 2 1 
 
Ale x P. Ma m u nes, M D (I nter nal Me dical Resi de nt; Gastr oe nter ol o g y Fell o w) 
R ole:  Pri mar y researc h me nt or, 2 0 1 8 - 2 0 2 0 
 
J or da n Orr, M D ( Gastr oe nter ol o g y Fell o w) 
R ole: Researc h c o m mittee me m ber, 2 0 1 8 - 2 0 2 0 
 
Fe deric o Ca m pisa n o, P h D ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h me nt or a n d dissertati o n c o-c hair, 2 0 1 5 - 2 0 2 0 
 
Sea n C. Rice, M D ( Gastr oe nter ol o g y Fell o w) 
R ole:  Pri mar y researc h me nt or, 2 0 1 5 - 2 0 2 0 
 
Pi otr Sla wi ns ki, P h D ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h me nt or a n d dissertati o n c o m mittee c o-c hair, 2 0 1 4 - 2 0 1 9 
 
Nic ol ó Gar bi n, P h D ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h me nt or a n d dissertati o n c o m mittee c o-c hair, 2 0 1 6 - 2 0 1 9 
 
A d dis u Ta d dese, P h D ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h me nt or a n d dissertati o n c o m mittee me m ber, 2 0 1 2 - 2 0 1 8 
 
Mic helle Iz ma yl o v, B S ( Me dical St u de nt) 
R ole: Pri mar y researc h me nt or, 2 0 1 5 - 2 0 1 6 
 
Cre ga n La b or de, M D ( Gastr oe nter ol o g y Fell o w) 
R ole: Pri mar y researc h me nt or, 2 0 1 4 - 2 0 1 6 
 
Marc o Becca ni, P h D ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h me nt or a n d dissertati o n c o m mittee me m ber, 2 0 1 1 - 2 0 1 5 

1 1  
 
 
C hristia n Di Natali, P h D ( Sc h o ol of E n gi neeri n g D oct oral St u de nt) 
R ole: Researc h me nt or a n d dissertati o n c o m mittee me m ber, 2 0 1 1 - 2 0 1 5 
Willia m F. Er ge n, M D (I nter nal Me dical Resi de nt) 
R ole:  Pri mar y researc h me nt or, 2 0 1 3 - 2 0 1 5 
 
A m y S. Sc hi n dler, M D ( Gastr oe nter ol o g y Fell o w) 
R ole: Pri mar y researc h me nt or, 2 0 1 1 - 2 0 1 3 
 
Eric P. Tra wic k, M D ( Gastr oe nter ol o g y Fell o w) 
R ole: Researc h c o m mittee me m ber, 2 0 1 1 - 2 0 1 3 
  
 
Vir gi nia Pe nsa be ne, P h D ( Sc h o ol of E n gi neeri n g P ost d oct oral sc h olar) 
R ole: Researc h c o m mittee me m ber, 2 0 1 1 - 2 0 1 3 
 
 
Rese arc h Pr o gr a m: 
St ate U ni versit y of Ne w Y or k at B uff al o  A d vis or: Israel Zi v, M D.  St u de nt researc her i n t he 
Ort h o pae dic Researc h La b orat or y c o n d ucti n g bi o mec ha nics a n d ort h o pae dic researc h, 1 9 9 7 – 
1 9 9 9  
 
J o h ns H o p ki ns U ni versit y  Me nt or: B or o Dj or dje vic, P h D, St u de nt researc her a n d desi g n 
pr oject c o or di nat or f or t he De part me nt of Materials Scie nce a n d E n gi neeri n g Ce nter f or 
N o n destr ucti ve E val uati o n, 1 9 9 9 - 2 0 0 0  
 
N ort h wester n U ni versit y Fei n ber g Sc h o ol of Me dici ne a n d Vrije U ni versiteit 
Me nt ors: Gerrit K. Ki ms ma, M D, M P h a n d T o d C ha m bers, P h D.  I n de pe n de nt researc h st u d y 
c o or di nate d bet wee n N ort h wester n U ni versit y Fei n ber g Sc h o ol of Me dici ne De part me nt of 
Me dical H u ma nities a n d Bi oet hics ( U S A) a n d t he Vrije U ni versiteit De part me nt of Meta me dica 
( A mster da m, T he Net herla n ds), c o n d ucte d i n T he Net herla n ds o n t he D utc h e x perie nce wit h 
e ut ha nasia, 2 0 0 1 – 2 0 0 6 
 
U ni versit y of Pe n ns yl v a ni a Sc h o ol of Me dici ne, Di visi o n of G astr oe nter ol o g y a n d t he 
Ce nter f or Cli nic al E pi de mi ol o g y & Bi ost atistics 
A d vis or: Y u- Xia o Ya n g, M D, M S C E 
Researc h pr oject o n c ol o n ca ncer scree ni n g i n t he de me nte d el derl y p o p ulati o n a n d se veral 
st u dies e xa mi ni n g t he relati o ns hi ps ass ociate d wit h t he de vel o p me nt of s p o nta ne o us bacterial 
perit o nitis, 2 0 0 5 – 2 0 0 7 
 
Ce nter f or I nte gr ati o n of Me dici ne a n d I n n o v ati ve Tec h n ol o g y ( CI MI T), I m a ge G ui d a nce 
L a b or at or y (I G L) 
Me nt or: Kir b y G. V os b ur g h, P h D 
Researc h pr ojects o n ki ne matics f or perf or ma nce meas ures i n e n d osc o p y, e n d osc o pic s kills 
assess me nt a n d trai ni n g, i ma ge re gistere d gastr osc o pic ultras o u n d (I R G U S), i ma ge re gistere d 
e n d osc o pic retr o gra de c h ola n gi o pa ncreat o gra p h y a n d i ma ge g ui da nce tec h n ol o g y i n e n d osc o p y, 
2 0 0 8 - 2 0 1 0 

1 2  
 
 
Bri g h a m a n d W o me n’s H os pit al, H ar v ar d Me dic al Sc h o ol 
Di visi o n of Gastr oe nter ol o g y, Secti o n of De vel o p me ntal E n d osc o p y 
Me nt or: C hrist o p her C. T h o m ps o n, M D, M Sc, F A C G, F A S G E 
Researc h pr ojects o n e n d osc o pic de vice de vel o p me nt, e n d osc o pic bariatric pr oce d ures/ o utc o mes, 
e n d osc o p y trai ni n g/e d ucati o n a n d Nat ural Orifice Tra nsl u mi nal E n d osc o pic S ur ger y ( N O T E S), 
2 0 0 8 – 2 0 1 0 
 
V a n der bilt U ni versit y Me dic al Ce nter  
Di visi o n of Gastr oe nter ol o g y 
Ce nter f or Tec h n ol o g y- G ui de d T hera p y 
S ur gical Na vi gati o n A p parat us Researc h La b orat or y ( S N A R L)  
Me nt or: R o bert L. Gall o wa y, Jr., P h D 
Ki ne matic data f or tec h nical perf or ma nce meas ures i n e n d osc o p y, e n d osc o pic s kills assess me nt 
a n d trai ni n g, i ma ge re gistere d c ol o n osc o p y, a n d i ma ge g ui da nce tec h n ol o g y i n e n d osc o p y.  
Q ualit y i m pr o ve me nt i n e n d osc o p y, 2 0 1 0 - Prese nt  
 
V a n der bilt U ni versit y 
De part me nt of Mec ha nical E n gi neeri n g 
Scie nce a n d Tec h n ol o g y of R o b otics i n Me dici ne 
T he S T O R M La b ( U S A , U K) 
U nite d States La b Direct or: Keit h L. O bstei n, M D, M P H, F A S G E, F A C G, A G A F 
U nite d Ki n g d o m La b Direct or: Pietr o Val dastri, P h D 
C olla b orat or a n d U S A la b direct or o n t he de vel o p me nt a n d i m ple me ntati o n of a ma g netic dri ve n 
wireless ca ps ule r o b ot f or utilizati o n i n gastr oi ntesti nal e n d osc o p y a n d s ur ger y, 2 0 1 1 - Prese nt  
 
V a n der bilt U ni versit y Me dic al Ce nter Di visi o n of G astr oe nter ol o g y; Ce nter f or H u m a n 
N utriti o n   
A pr os pecti ve, m ulti-ce nter re gistr y f or patie nts wit h s h ort b o wel s y n dr o me. T E D- R 1 3- 0 0 2 
Pri nci pal I n vesti gat or: Keit h L. O bstei n, M D, M P H, 2 0 1 4 - 2 0 1 6 
 
 
Till otts P h ar m a; C a ncer Pre ve nti o n P h ar m ace utic als  
A d o u ble- bli n d, ra n d o mize d, p hase III trial of t he safet y a n d efficac y of C P P- 1 X/ S uli n dac 
c o m pare d wit h C P P- 1 X, S uli n dac as si n gle a ge nts i n patie nts wit h fa milial a de n o mat o us 
p ol y p osis ( F A P).  C P P F A P- 3 1 0; C P P- 1 X = D F M O = Efl or nit hi ne  
Site Pri nci pal I n vesti gat or: Ti m ot h y Gei ger, M D, 2 0 1 4 - 2 0 2 0 
 
Free n o me; P R E E M P T C R C: P R E ve nti o n E m pl o yi n g a M ulti o mics Pl as m a- b ase d Test f or 
C ol o Rect al C a ncer  
A lar ge re gistrati o nal, m ulti- site, Pre- Mar ket A p pr o val st u d y of a bl o o d base d test f or c ol orectal 
ca ncer scree ni n g i n 1 4, 0 0 0 patie nts u n der g oi n g a ge a p pr o priate a vera ge ris k c ol o n osc o p y.  Bl o o d 
sa m ple c ollecte d pri or t o b o wel pre parati o n a n d c ol o n osc o p y.  F R N M 0 0 4: Site 0 5 1. 
Site Pri nci pal I n vesti gat or: Keit h L. O bstei n, M D, M P H,  2 0 2 0 - Prese nt 
 
 
 
Rese arc h F u n di n g : 
Ce nter f or I nte gr ati o n of Me dici ne a n d I n n o v ati ve Tec h n ol o g y ( CI MI T) Gr a nt   

1 3  
 
C ol o n osc o p y : Ki ne matics- base d metrics t o i m pr o ve perf or ma nce a n d trai ni n g 
CI MI T, De part me nt of Defe nse U S A M R A A 
W 8 1 X W H- 0 7- 2- 0 1 1 
( $ 9 7, 5 4 5) 
T o i m pr o ve t he q ualit y of c ol o n osc o p y a n d efficie nc y of trai ni n g b y esta blis hi n g be nc h mar k 
perf or ma nce metrics a n d sta n dar ds t hat c haracterize le vels of e x pertise i n c ol o n osc o p y, 2 0 1 1-
2 0 1 2 
 
V a n der bilt I nstit ute f or S ur ger y a n d E n gi neeri n g (Vi S E ) Gr a nt   
A n o vel r o b otic platf or m f or c ol orectal ca ncer scree ni n g 
Va n der bilt U ni versit y, Vi S E/ VI C T R 
C o-I ( $ 3 0, 0 0 0) 
T o de vel o p a n o vel tec h ni q ue f or c ol orectal ca ncer scree ni n g b y har nessi n g mes o-scale ma g netic 
r o b ots, 2 0 1 2- 2 0 1 3 
 
V a n der bilt Disc o ver y Gr a nt  
Defeati n g c ol orectal ca ncer b y a n o vel r o b otic a p pr oac h f or scree ni n g 
Va n der bilt U ni versit y, U ni versit y Ce ntral 
C o-I ( $ 9 9, 9 8 8)  
  
  
  
  
  
 
T o i nte grate a ut ofl u oresce nce a n d o ptical s pectr osc o p y wit h ma g netic ma ni p ulati o n of a ca ps ule 
r o b ot t o i m pr o ve dia g n osis of c ol orectal ca ncer, 2 0 1 2- 2 0 1 4 
 
Gi ve n I m a gi n g, Lt d.  
Meas ure me nt of Fricti o n i n t he I ntesti ne 
C o-I ( $ 1 0, 0 0 0) 
T o meas ure t he fricti o n t hat a ma g netic ca ps ule m ust o verc o me t o m o ve i n t he s mall i ntesti ne, 
0 2/ 2 0 1 3 – 1 1/ 2 0 1 3 
 
T he Br o a d F o u n d ati o n  
De vel o p me nt a n d pre-cli nical vali dati o n of a s oft-tet here d e n d osc o pic r o b ot t o re place 
c ol o n osc o p y 
C o-I ( $ 1 1 0, 0 0 0) 
T his see d gra nt s u p p orts t he o pti mizati o n of a r o b otic platf or m f or ma g netic c ol o n osc o p y, 
f oc usi n g o n ma g netic c o u pli n g r o b ust ness, real-ti me trac ki n g of ca mera p ose, a n d t he 
preli mi nar y de vel o p me nt of a n i nt uiti ve c o ntr oller.  T he o utc o mes of t his s h ort pr oject will 
pr o vi de a d diti o nal preli mi nar y res ults f or t he w or k pr o p ose d i n t he prese nt a p plicati o n, 2 0 1 3-
2 0 1 4 
 
N ati o n al Scie nce F o u n d ati o n ( N S F)   
C O 2 I ns ufflat or f or Mi ni mall y I n vasi ve Pr oce d ures 
C o-I ( $ 5 0, 0 0 0) 
T he g oal of t his pr oject is t o de vel o p a n d assess a dis p osa ble a n d l o w-c ost C O 2 i ns ufflat or base d 
o n a n effer vesce nt reacti o n t o be use d d uri n g sta n dar d c ol o n osc o p y, 2 0 1 3- 2 0 1 4 
 
N ati o n al I nstit utes of He alt h ( NI H) R 0 1 ( 2 0 1 4- 2 0 2 0) 
A ma g netic ca ps ule e n d osc o pe f or c ol o n osc o p y i n patie nts wit h I B D ( $ 1, 5 0 4, 3 9 4. 6 4) 
5 R 0 1 E B 0 1 8 9 9 2- 0 3 
Pri nci pal I n vesti gat or ( PI) 2 0 1 6- 2 0 2 0 

1 4  
 
1 R 0 1 E B 0 1 8 9 9 2- 0 1 
C o-I 2 0 1 4- 2 0 1 6 
Pre pari n g a n o vel r o b otic ma g netic c ol o n ca ps ule e n d osc o p y platf or m f or F D A a p pr o val. 
 
 
V a n der bilt I nstit ute f or S ur ger y a n d E n gi neeri n g (Vi S E ) Gr a nt   
Ultra-l o w-c ost e n d osc o p y f or gastric ca ncer scree ni n g i n Ce ntral A merica. 
Va n der bilt U ni versit y, Vi S E/ VI C T R 
PI ( $ 4 0, 0 0 0) 
O pti mizati o n of a n o vel platf or m f or gastric ca ncer scree ni n g i n l o w- a n d mi d dle-i nc o me 
c o u ntries, 2 0 1 6 
 
E n gi neeri n g a n d P h ysic al Scie nces Rese arc h C o u ncil ( E P S R C) Gr a nt   
Ultra-l o w-c ost e n d osc o p y f or gastric ca ncer scree ni n g i n r ural C hi na. 
E P/ P 0 2 7 9 3 8/ 1 
Visiti n g Researc her ( £ 1, 5 8 4, 5 2 8. 9 0) 
O pti mizati o n of a n o vel platf or m f or gastric ca ncer scree ni n g i n r ural C hi na. 
 
Hi g her E d uc ati o n F u n di n g C o u ncil f or E n gl a n d ( H E F C E) Gr a nt   
Ultra-l o w-c ost dia g n osis of Helic o b acter Pyl ori  i n r ural I n dia. 
PI of S u bc o ntract A war d ( £ 4 0, 0 0 0. 0 0) 
O pti mizati o n of a n o vel platf or m f or dia g n osis of H. P yl ori i n r ural I n dia, 2 0 1 8- 2 0 1 9 
 
A meric a n G astr oe nter ol o gic al Ass oci ati o n ( A G A)- B ost o n Scie ntific Tec h n ol o g y a n d 
I n n o v ati o n Pil ot Rese arc h A w ar d 2 0 1 8 
W hi pc or d A ut o mate d Necr osect o m y De bri de me nt ( W A N D) de vice: pr ot ot y pe de vel o p me nt a n d 
ex viv o testi n g. 
C olla b orat or ( $ 3 0, 0 0 0) 
Desi g n a n d b uil d a W A N D de vice c o m pati ble f or use wit h a fle xi ble e n d osc o pe a n d ca pa ble of 
selecti ve tiss ue fra g me ntati o n. 
 
C a ncer Rese arc h U nite d Ki n g d o m ( C R U K) Gr a nt  
A r o b otic ma g netic fle xi ble e n d osc o pe f or pai nless c ol orectal ca ncer scree ni n g, s ur veilla nce a n d 
i nter ve nti o n. 
A 2 7 7 4 4 
C olla b orat or ( £ 1, 1 2 9, 3 6 7. 0 7) 
O pti mize a n d c o n d uct a first i n- h u ma n feasi bilit y st u d y of o ur ma g netic fle xi ble e n d osc o pe 
( M F E) r o b otic platf or m. 
 
N ati o n al I nstit ute f or He alt h Rese arc h ( NI H R) Gr a nt  
A n i n n o vati o n i n sa me- da y b o wel clea ni n g a n d bl oc ka ge re m o val. 
C olla b orat or ( £ 1 0, 0 0 0) 
A war d f or cli nicall y dri ve n t he me: T he f ut ure of s ur ger y.  Desi g n a n d e val uati o n of a n o vel 
platf or m f or b o wel clea nsi n g pri or t o c ol o n osc o p y i n patie nts wit h C ystic Fi br osis ( C F). 
 

1 5  
 
N ati o n al I nstit utes of He alt h ( NI H) R 4 1 ( 2 0 1 9- 2 0 2 1) 
E na bli n g de xter o us s ur ger y at t he ti p of a fle xi ble e n d osc o pe: A l o w-c ost, dis p osa ble, steera ble 
s heat h. 
R 4 1 E B 0 2 8 2 2 9 
C o-I ( $ 1 5 1, 5 6 5) 
T o b uil d a r o b otic s yste m t hat will e na ble pr o of of c o nce pt f or a ne w bi ma n ual e n d osc o pic 
de vice w hic h will assist wit h t he re m o val of c ol o n p ol y ps. 
 
N ati o n al I nstit utes of He alt h ( NI H) R 4 4 ( 2 0 2 0- prese nt) 
S q uas hi n g t he sc o pe s u per b u g: A dis p osa ble s yste m f or E R C P t hat sa ves patie nts fr o m bacterial 
cr oss-c o nta mi nati o n. 
R 4 4 D K 1 2 6 6 0 6 
C olla b orat or ( $ 9 8 3, 7 4 9) 
T his s u p p orts t he mec ha nical desi g n, ma n ufact uri n g, a n d e x peri me ntal vali dati o n of a n o vel 
dis p osa ble s yste m t hat places t he f u ncti o nalit y of a n E R C P e n d osc o pe i nt o a sta n dar d f or war d 
vie wi n g e n d osc o pe. 
 
N ati o n al I nstit utes of He alt h ( NI H) R 0 1 ( 2 0 2 1- prese nt) 
A ma g netic ca ps ule e n d osc o pe f or c ol o n osc o p y i n patie nts wit h I B D ( $ 1, 2 6 4, 5 5 2) 
2 R 0 1 E B 0 1 8 9 9 2- 0 5 
Pri nci pal I n vesti gat or ( PI) 
Pre pari n g a n o vel r o b otic ma g netic fle xi ble e n d osc o p y platf or m f or first- i n- h u ma n trials a n d 
de vel o p me nt of a n o vel c ol o n vis ualizati o n i n de x. 
 
V a n der bilt I nstit ute f or S ur ger y a n d E n gi neeri n g (VI S E ) Gr a nt ( 2 0 2 1- prese nt)  
Assist -as- nee de d i ntelli ge nt ha ptics f or trai ni n g a n d se mi-a ut o mati o n of c ol o n osc o p y. 
Va n der bilt U ni versit y, VI S E/ VI C T R 
C o- PI ( $ 2 0, 0 0 0) 
De vel o p me nt of a n assist- as- nee de d platf or m f or facilitati o n of e n d osc o pic trai ni n g a n d 
pr oce d ural tec h nical efficie nc y. 
 
 
 
P ate nts: 
T h o m ps o n C C, Wester velt R, Ne mir os ki A, O bstei n K L . S yste m a n d met h o d f or wireless 
bi ose ns or m o nit ori n g.  U S Pate nt A p plicati o n 2 0 1 3 0 0 1 8 2 3 5; file d N o ve m ber 2 0 1 0. 
 
Ger di n g J, S mit h B F, O bstei n K L , Val dastri P.  Tet herless I ns ufflati o n t o E na ble Wireless 
Ca ps ule E n d osc o p y.  U S Pate nt A p plicati o n 4/ 0 2 9, 6 8 7; pri orit y date Se pte m ber 1 7, 2 0 1 2. 
 
Becca ni M, Di Natali C, O bstei n K L , Val dastri P.  Real-ti me p ose a n d ma g netic f orce detecti o n 
f or a wireless ma g netic ca ps ule.  U S Pr o visi o nal A p plicati o n 6 1/ 7 5 3, 7 5 5; file d Ja n 1 7, 2 0 1 3; 
c o n verte d t o P C T/ U S 2 0 1 4/ 0 1 2 0 8 6 o n Ja n uar y 1 7, 2 0 1 4. 
 
S mit h B F, O bstei n K L , Val dastri P.  I ns ufflati o n a n d C O 2 Deli ver y f or Mi ni mall y I n vasi ve 
Pr oce d ures.  U S Pate nt Pr o visi o nal A p plicati o n 6 1/ 8 6 4, 8 1 9; file d A u g 1 2, 2 0 1 3; c o n verte d t o 
P C T/ U S 2 0 1 4/ 4 5 7, 6 7 6 o n A u g ust 1 2, 2 0 1 4. 

1 6  
 
 
Val dastri P, O bstei n K L , Ca prara R, L y ne C, Ca m pisa n o F, Sc ozzarr o G, Varta nia n A, J o nes W, 
Di Natali C, Becca ni M, Er de mir E.  H y dr ojet E n d osc o pic Ca ps ule a n d Met h o ds f or Gastric 
Ca ncer Scree ni n g i n L o w-res o urce Setti n gs.  U S Pate nt P C T/ U S 1 5/ 4 9 1 4 2 o n Se pte m ber 9, 2 0 1 5. 
 
Sla wi ns ki P, Ta d dese A Z, O bstei n K L , Val dastri P.  R o b otic ca ps ule s yste m wit h ma g netic 
act uati o n a n d l ocalizati o n.  U S Pate nt A p plicati o n 1 6/ 1 5 5, 6 3 7; file d Oct o ber 9, 2 0 1 8. 
 
Yac hi ms ki P S, La n da wee C A, Ca m pisa n o F, Val dastri P, O bstei n K L .  S yste m a n d de vice f or 
waterjet necr osect o m y.  U S Pate nt A p plicati o n 1 7/ 3 0 6, 7 0 8; file d Ma y 3, 2 0 2 1; c o n verte d t o U S 
Pate nt U S 2 0 2 1/ 0 3 3 8 2 6 3 A 1 o n N o ve m ber 4, 2 0 2 1. 
 
 
  
 
P u blic ati o ns: 
 
O bstei n K L , Ki ms ma G K, C ha m bers T.  Practici n g E ut ha nasia: T he Pers pecti ve of 
P h ysicia ns.  J o ur nal of Cli nical Et hics. 2 0 0 4; 1 5( 3): 2 2 3- 3 1. 
 
Ki ms ma G K, O bstei n K L , C ha m bers T.  A Res p o nse t o S hal o witz a n d E ma n uel.  J o ur nal of 
Cli nical Et hics. 2 0 0 5; 1 6( 2): 1 7 6 -7 8.  
 
Ca m p bell M S, O bstei n K L , Re d d y K R, Ya n g Y X.  Ass ociati o n bet wee n Pr ot o n P u m p 
I n hi bit or Use a n d S p o nta ne o us Bacterial Perit o nitis.  Di gesti ve Diseases a n d Scie nces. 2 0 0 8; 
5 3( 2): 3 9 4 -8.  E p u b 2 0 0 7, J ul 7.  
 
O bstei n K L , Ca m p bell M S, Re d d y K R, Ya n g Y X.  Ass ociati o n of M o del f or E n d- Sta ge Li ver 
Disease ( M E L D) sc ore wit h S p o nta ne o us Bacterial Perit o nitis.  A merica n J o ur nal of 
Gastr oe nter ol o g y. 2 0 0 7; 1 0 2( 1 2): 2 7 3 2 -6.  E p u b 2 0 0 7, A u g 2 1.  
 
O bstei n K L , Slatter y J, Carr- L oc ke D, T h o m ps o n C C.  E n d osc o pic Re pair of a T y pe II 
Paraes o p ha geal Her nia wit h Mese nter oa xial V ol v ul us [ vi de o].  
htt p:// da ve pr oject. or g/ vie wfil ms.cf m?fil m _i d = 8 6 8.  P u blis he d J u ne 1, 2 0 0 9.  Accesse d J ul y 2 1, 
2 0 1 0. 
  
Pa gi di pati N, O bstei n K L , R uc ker- Sc h mi dt R, O dze R D, T h o m ps o n C C.  Ac ute He patitis d ue 
t o E pstei n- Barr Vir us i n a n I m m u n oc o m pete nt Patie nt.  Di gesti ve Diseases a n d Scie nces. 
2 0 1 0; 5 5( 4): 1 1 8 2- 5.  E p u b Ma y 2 1, 2 0 0 9. 
 
O bstei n K L , T h o m ps o n C C.  E n d osc o p y After Bariatric S ur ger y ( wit h vi de os).  
Gastr oi ntesti nal E n d osc o p y. 2 0 0 9; 7 0( 6): 1 1 6 1- 6.  E p u b 2 0 0 9, J ul y 3 1. 
 
O bstei n K L , Ja ye n der J, Patil V D, Sa n J osé- Esté par R, S p off or d I S, Le n g yel BI, R ya n M B, 
V os b ur g h K G, T h o m ps o n C C.  I ma ge G ui de d Tec h n ol o g y i n E n d osc o p y [ vi de o].  
htt p:// da ve pr oject. or g/ vie wfil ms.cf m?fil m _i d = 9 0 6.  P u blis he d Ma y 3, 2 0 1 0.  Accesse d J ul y 2 1, 
2 0 1 0. 
  

1 7  
 
O bstei n K L , Marti ns F P, Fer ná n dez- Es parrac h G, T h o m ps o n C C.  E n d osc o pic Ultras o u n d 
( E U S)- g ui de d Celiac Ple x us Ne ur ol ysis ( C P N) usi n g a Re verse P hase P ol y mer: A n I nitial 
E val uati o n i n a P orci ne M o del.  W orl d J o ur nal of Gastr oe nter ol o g y. 2 0 1 0; 1 6( 6): 7 2 8- 3 1. 
 
O bstei n K L , Patil V D, Ja ye n der J, Sa n J osé- Esté par R, S p off or d I S, Le n g yel BI, V os b ur g h 
K G, T h o m ps o n C C.  E val uati o n of C ol o n osc o p y Tec h nical S kill Le vels b y use of a n O bjecti ve 
Ki ne matic- Base d S yste m.  Gastr oi ntesti nal E n d osc o p y.  2 0 1 1; 7 3: 3 1 5- 3 2 1.   
 
O bs tei n K L, Sa n J osé- Esté par R, Ja ye n der J, Patil V D, S p off or d I S, R ya n M B, Le n g yel BI, 
S ha ms R, V os b ur g h K G, T h o m ps o n C C.  I ma ge Re gistere d Gastr osc o pic Ultras o u n d (I R G U S) 
i n H u ma n S u bjects: A Pil ot St u d y t o Assess Feasi bilit y.  E n d osc o p y.  2 0 1 1; 4 3: 3 9 4- 3 9 9.  E p u b 
2 0 1 1, Marc h 2 1. 
  
C ha n W W, C hi o u E, O bstei n K L , Ti g n or A S, W hitl oc k T L.  T he Efficac y of Pr ot o n P u m p 
I n hi bit ors f or t he Treat me nt of Ast h ma i n A d ults: A Meta- A nal ysis.  Arc hi ves of I nter nal 
Me dici ne.  2 0 1 1; 1 7 1: 6 2 0- 6 2 9. 
 
Sc hi n dler A E, Sc h nei der J, O bstei n K L .  F oa mi n g at t he m o ut h: i n gesti o n of 3 5 % h y dr o ge n 
per o xi de s ol uti o n ( wit h vi de o).  Cli nical Gastr oe nter ol o g y a n d He pat ol o g y.  2 0 1 2; 1 0:e 1 3- 1 4.  
E p u b 2 0 1 1, Oct 5. 
  
G orle wicz J L, Batta glia S, S mit h B F, Ci uti G, Ger di n g J, Me nciassi A, O bstei n K L , Val dastri 
P, We bster RJ.  Wireless i ns ufflati o n of t he gastr oi ntesti nal tract.  I E E E Tra nsacti o ns o n 
Bi o me dical Me dical E n gi neeri n g.  2 0 1 2; N o v 2 9. [ E p u b a hea d of pri nt] P MI D: 2 3 2 1 2 3 1 2. 
 
O bstei n K L , Batta glia S, S mit h B F, Ger di n g J, Val dastri P.  N o vel a p pr oac h f or c ol o nic 
i ns ufflati o n via a n u ntet here d ca ps ule ( wit h vi de o).  Gastr oi ntesti nal E n d osc o p y. 2 0 1 3; 7 7: 5 1 6-
7. d oi: 1 0. 1 0 1 6/j. gie. 2 0 1 2. 1 0. 0 1 0. 
  
A S G E Trai ni n g C o m mittee 2 0 1 1- 2 0 1 2, Raja n E A, Pais S A, De gre g ori o B T, A dler D G, Al-
Ha d da d M, Ba kis G, C o yle WJ, Da vila, Di Mai o CJ, E nest ve dt B K, J or ge nse n J, Lee L S, 
M ulla d y D K, O bstei n K L , Se dlac k R E, Tier ne y W M, Fa ul x A L.  S mall- b o wel e n d osc o p y 
c ore c urric ul u m.  Gastr oi ntesti nal E n d osc o p y. 2 0 1 3; 7 7: 1- 6.  d oi: 1 0. 1 0 1 6/j. gie. 2 0 1 2. 0 9. 0 2 3. 
  
O bstei n K L , Val dastri P.  A d va nce d E n d osc o pic Tec h n ol o gies f or C ol orectal Ca ncer 
Scree ni n g.  W orl d J o ur nal of Gastr oe nter ol o g y.  2 0 1 3; 1 9: 4 3 1- 4 3 9. 
 
Bell C S, O bstei n K L , Val dastri P.  I ma ge partiti o ni n g a n d ill u mi nati o n i n i ma ge- base d p ose 
detecti o n f or tele o perate d fle xi ble e n d osc o pes.  Artificial I ntelli ge nce i n Me dici ne.  
2 0 1 3; 5 9; 1 8 5- 9 6. E p u b 2 0 1 3, Oct 1 0.  P MI D: 2 4 1 8 8 5 7 5. 
 
A S G E Trai ni n g C o m mittee 2 0 1 2- 2 0 1 3, Se dlac k R E, C o yle, WJ, O bstei n K L , Al- Ha d da d M, 
Ba kis G, C hristie J A, Da vila R E, De gre g ori o B T, Di Mai o CJ, E nest ve dt B K, J or ge nse n J, 
M ulla d y D K, Raja n L.  A S G E’s assess me nt of c o m pete nc y i n e n d osc o p y e val uati o n t o ols f or 
c ol o n osc o p y a n d E G D.  Gastr oi ntesti nal E n d osc o p y. 2 0 1 4; 7 9: 1- 7. E p u b 2 0 1 3, N o v 1 4. P MI D: 
2 4 2 3 9 2 5 5. 
 

1 8  
 
A S G E Trai ni n g C o m mittee 2 0 1 3- 2 0 1 4, E nest ve dt B K, J or ge nse n J, Se dlac k R E, C o yle, WJ, 
O bstei n K L , Al- Ha d da d M, C hristie J A, Da vila R E, M ulla d y D K, K u bili u n N, K w o n R S, La w 
R, Q ures hi W A. E n d osc o pic a p pr oac hes t o e nteral fee di n g a n d n utriti o n c ore c urric ul u m.  
Gastr oi ntesti nal E n d osc o p y. E p u b 2 0 1 4, A pril 2 5. P MI D: 2 4 7 7 3 7 7 3. 
 
Pasric ha T, S mit h B F, Mitc hell V R, Fa n g B, Br o o ks E R, Ger di n g J S, Was hi n gt o n M K, 
Val dastri P, O bstei n K L .  C o ntr olle d c ol o nic i ns ufflati o n b y a re m otel y tri g gere d ca ps ule f or 
i m pr o ve d m uc osal vis ualizati o n.  E n d osc o p y. 2 0 1 4; 4 6: 6 1 4- 6 1 8.  E p u b 2 0 1 4, Ma y 2 0. P MI D: 
2 4 8 4 5 8 0 2.  
 
Di Natali C, Becca ni M, O bstei n K L , Val dastri P.  A wireless platf or m f or i n viv o 
meas ure me nt of resista nce pr o perties of t he gastr oi ntesti nal tract.  P h ysi ol o gical Meas ure me nt. 
2 0 1 4; 3 5: 1 1 9 7- 1 2 1 4. E p u b 2 0 1 4, Ma y 2 2. P MI D: 2 4 8 5 2 8 1 0. 
 
Sc hi n dler A E, C ha n W W, La b or de CJ, O bstei n K L .  Relia bilit y of t he B ost o n B o wel 
Pre parati o n Scale i n t he e n d osc o p y n urse p o p ulati o n.  Cli n Gastr oe nter ol He pat ol. 2 0 1 4, N o v 
1 5. P MI D: 2 5 4 6 0 5 5 9. 
 
Ca prara RJ, O bstei n K L , Sc ozzarr o G, Di Natali C, Becca ni M, M or ga n D R, Val dastri P. A 
platf or m f or gastric ca ncer scree ni n g i n l o w- a n d mi d dle-i nc o me c o u ntries.  I E E E Tra ns 
Bi o me d E n g. 2 0 1 5; 6 2( 5): 1 3 2 4- 3 2.  E p u b 2 0 1 4, Dec 3 0. P MI D: 2 5 5 6 1 5 8 6. 
 
S lawi ns ki P R, O bstei n K L , Val dastri P.  E mer gi n g iss ues a n d f ut ure de vel o p me nts i n ca ps ule 
e n d osc o p y.  Tec h ni q ues i n Gastr oi ntest E n d osc.  2 0 1 5; 1 7( 1): 4 0- 4 6. P MI D: 2 6 0 2 8 9 5 6.  
 
Se dlac k R E, C o yle WJ, O bstei n K L , P oles M A, Ra mirez F C, L u ke ns FJ, G ya wali C P, 
C hristie J A, Kal maz D, B ur ke C A, E n ders F, Lars o n JJ, O xe nte n k o A S.  Assess me nt of 
c o m pete nc y i n e n d osc o p y: esta blis hi n g a n d vali dati n g ge neraliza ble c o m pete nc y be nc h mar ks 
f or c ol o n osc o p y.  Gastr oi ntest E n d osc.  2 0 1 6; 8 3( 3): 5 1 6- 2 3.e 1; E p u b 2 0 1 5; J u ne 1 3. P MI D: 
2 6 0 7 7 4 5 5. 
 
S lawi ns ki P R, O bstei n K L , Val dastri P.  Ca ps ule e n d osc o p y of t he f ut ure: W hat’s o n t he 
h oriz o n?  W orl d J o ur nal of Gastr oe nter ol o g y.  2 0 1 5; 2 1( 3 7): 1 0 5 2 8- 4 1. P MI D: 2 6 4 5 7 0 1 3.  
 
Er ge n W F, Pasric ha T, H u b bar d FJ, Hi g gi n b ot ha m T, Gi ve ns T, Sla u g hter J C, O bstei n K L .  
Pr o vi di n g h os pitalize d patie nts wit h a n e d ucati o nal b o o klet i ncreases t he q ualit y of 
c ol o n osc o p y b o wel pre parati o n.  Cli n Gastr oe nter ol He pat ol.  2 0 1 6; 1 4( 6): 8 5 8- 6 4. P MI D: 
2 6 6 8 1 4 8 7. 
 
A S G E Trai ni n g C o m mittee, J or ge nse n J, K u bili u n N, La w J K, Al - Ha d da d M, Bi n ge ner- Case y 
J, C hristie J A, Da vila R E, K w o n R S, O bstei n K L , Q ures hi W A, Se dlac k R E, Wa g h M S, 
Za nc hetti D, C o yle WJ,  C o he n J.  E n d osc o pic retr o gra de c h ola n gi o pa ncreat o gra p h y ( E R C P): 
c ore c urric ul u m.  Gastr oi ntesti nal E n d osc o p y. 2 0 1 6; 8 3( 2): 2 7 9- 8 9. P MI D: 2 6 7 0 8 0 8 1. 
 
Ji m o h L Y, O bstei n K L .  I m pr o vi n g pr oce d ure l o g gi n g a m o n g Gastr oe nter ol o g y trai nees usi n g 
a m o bile a p plicati o n.  J C o m p ut Sci S yst Bi ol.  E p u b 2 0 1 6 Ja n 2 0. 
 

1 9  
 
Becca ni M, Di Natali C, Val dastri P, O bstei n K L .  Rest ori n g ha ptic fee d bac k i n N O T E S 
pr oce d ures wit h a n o vel wireless tiss ue stiff ness pr o be.  J Me d R o b otics Researc h.  E p u b 2 0 1 6 
Ja n 2 8. 
 
La b or de CJ, Bell C S, Sla u g hter J C, Val dastri P, O bstei n K L .  E val uati o n of a n o vel ta blet 
a p plicati o n f or i m pr o ve me nt i n c ol o n osc o p y trai ni n g a n d me nt ori n g ( wit h vi de o).  
Gastr oi ntesti nal E n d osc o p y. 2 0 1 7; 8 5( 3): 5 5 9- 5 6 5.e 1.  P MI D 2 7 4 8 0 2 8 9 
 
Rice S C, Hi g gi n b ot ha m T, Dea n MJ, Sla u g hter J C, Yac hi ms ki P S, O bstei n K L .  Vi de o o n diet 
pri or t o o ut patie nt c ol o n osc o p y d oes n ot i m pr o ve q ualit y of b o wel pre parati o n: A pr os pecti ve, 
ra n d o mize d, c o ntr olle d trial.  A merica n J o ur nal of Gastr oe nter ol o g y. 2 0 1 6; 1 1 1( 1 1): 1 5 6 4-1 5 7 1.  
P MI D: 2 7 7 5 3 4 3 4. 
 
Ta d dese A Z, Sla wi ns ki P, O bstei n K L , Val dastri P.  Cl ose d l o o p c o ntr ol of a tet here d 
ma g netic ca ps ule e n d osc o pe.  R o b ot Sci S yst. 2 0 1 6 J u n; 2 0 1 6.  P MI D: 2 8 2 8 6 8 8 6. 
 
Ta d dese A Z, Sla wi ns ki P, O bstei n K L , Val dastri P.  N o n h ol o n o mic cl ose d-l o o p vel ocit y 
c o ntr ol of a s oft-tet here d ma g netic ca ps ule e n d osc o pe.  Re p U S. 2 0 1 6; Oct 1 1 3 9- 1 1 4 1. E p u b 
2 0 1 6 Dec 1. P MI D: 2 8 3 1 6 8 7 3. 
 
Sla wi ns ki P, Ta d dese A Z, M ust o K B, O bstei n K L , Val dastri P.  A ut o n o m o us retr ofle xi o n of a 
ma g netic fle xi ble e n d osc o pe.  I E E E R o b ot A ut o m Lett. 2 0 1 7; 2( 3): 1 3 5 2- 1 3 5 9. E p u b 2 0 1 7 Fe b 
1 3. P MI D: 2 8 2 8 9 7 0 3. 
 
Ca m pisa n o F, Gra m u glia F, Da ws o n I R, L y ne C T, Iz ma yl o v M L, Misra S, De M o mi E, 
M or ga n D R, O bstei n K L , Val dastri P.  Gastric ca ncer scree ni n g i n l o w-i nc o me c o u ntries: 
S yste m desi g n, fa bricati o n, a n d a nal ysis f or a n ultra-l o w c ost e n d osc o p y pr oce d ure.  I E E E 
R o b ot A ut o m Ma g. 2 0 1 7; 2 4( 2): 7 3- 8 1. E p u b 2 0 1 7 Ma y 1 1. P MI D: 2 8 9 5 9 1 1 8. 
 
A S G E Trai ni n g C o m mittee, K w o n R S, Da vila R E, M ulla d y D K, Al - Ha d da d M, Ba n g J Y, 
Bi n ge ner- Case y J, B os w ort h B P, C hristie J A, C ote G A, Dia m o n d S, J or ge nse n J, K o wals ki 
T E, K u bili u n N, La w J K, O bstei n K L , Q ures hi W A, Ra mirez F C, Se dlac k R E, Tsai F, 
Vi g nes h S, Wa g h M S, Za nc hetti D, C o yle WJ,  C o he n J.  E G D c ore c urric ul u m.  Vi de o GI E. 
2 0 1 7; 2( 7): 1 6 2- 1 6 8. P MI D: 2 9 9 0 5 3 0 1. 
 
Sla wi ns ki P, Ta d dese A Z, M ust o K B, Sar ker S, Val dastri P, O bstei n K L .  A ut o n o m o usl y 
c o ntr olle d ma g netic fle xi ble e n d osc o pe f or c ol o n e x pl orati o n.  Gastr oe nter ol o g y. 
2 0 1 8; 1 5 4( 6): 1 5 7 7- 1 5 7 9.e 1. E p u b 2 0 1 8 Mar 9. P MI D: 2 9 5 3 0 3 7 7. 
 
Ta d dese A Z, Sla wi ns ki P, Pir otta M, De M o mi E, O bstei n K L , Val dastri P.  E n ha nce d real-
ti me p ose esti mati o n f or cl ose d l o o p r o b otic ma ni p ulati o n of ma g neticall y act uate d ca ps ule 
e n d osc o pes.  I nter nati o nal J o ur nal of R o b otics Researc h. 2 0 1 8; 3 7( 8): 8 9 0- 9 1 1. P MI D: 
3 0 1 5 0 8 4 7. 
 
Gar bi n N, Wa n g L, C ha n dler J H, O bstei n K L , Si maa n N, Val dastri P.  D ual- C o nti n u u m 
Desi g n A p pr oac h f or I nt uiti ve a n d L o w- C ost U p per Gastr oi ntesti nal E n d osc o p y.  I E E E 
Tra nsacti o ns o n Bi o me dical Me dical E n gi neeri n g.  2 0 1 9; 6 6( 7): 1 9 6 3- 1 9 7 4. E p u b 2 0 1 8; N o v 
1 6 . P MI D: 3 0 4 5 2 3 4 8.  

2 0  
 
 
Sca gli o ni B, Per vitera L, Marti n J, N ort o n J, O bstei n K L , Val dastri P.  E x plicit M o del 
Pre dicti ve C o ntr ol of a Ma g netic Fle xi ble E n d osc o pe.  I E E E R o b ot A ut o m Lett. 
2 0 1 9; 4( 2): 7 1 6- 7 2 3. E p u b 2 0 1 9 Ja n 1 6. P MI D: 3 0 9 3 1 9 2.  
 
Pitti gli o G, Bar d ucci L, Marti n J W, N ort o n J C, A vizza n o C A, O bstei n K L , Val dastri P.  
Ma g netic le vitati o n f or s oft-tet here d ca ps ule c ol o n osc o p y act uate d wit h a si n gle per ma ne nt 
ma g net: A d y na mic c o ntr ol a p pr oac h.  I E E E R o b ot A ut o m Lett. 2 0 1 9; 4( 2): 1 2 2 4- 1 2 3 1. E p u b 
2 0 1 9 Ja n 2 3.  P MI D: 3 1 3 0 4 2 4 0. 
 
Miller A T, Se dlac k R E, C o yle WJ, O bstei n K L , P oles M A, Ra mirez F C, L u ke ns FJ, G ya wali 
C P, C hristie J A, Kal maz D, E n ders F, Lars o n JJ, O xe nte n k o A S.  C o m pete nc y i n 
es o p ha g o gastr o d u o de n osc o p y: a vali date d t o ol f or assess me nt a n d ge neraliza ble be nc h mar ks 
f or gastr oe nter ol o g y fell o ws.  Gastr oi ntest E n d osc.  E p u b 2 0 1 9 Ma y 2 0.  P MI D: 3 1 1 2 1 1 5 4. 
 
Sla wi ns ki P, Si maa n N, Ta d dese A Z, O bstei n K L , Val dastri P.  Se nsiti vit y elli ps oi ds f or f orce 
c o ntr ol of ma g netic r o b ots wit h l ocalizati o n u ncertai nt y.  I E E E Tra nsacti o ns o n R o b otics. 
2 0 1 9; 3 5( 5): 1 1 2 3- 1 1 3 5.  E p u b 2 0 1 9 J u ne 1 1. P MI D: 3 1 6 0 7 8 3 3. 
 
Sla wi ns ki P, Si maa n N, O bstei n K L , Val dastri P.  Se ns orless esti mati o n of t he pla nar distal 
s ha pe of a ti p-act uate d e n d osc o pe.  I E E E R o b ot A ut o m Lett. 2 0 1 9; 4( 4): 3 3 7 1- 3 3 7 7.  E p u b 2 0 1 9 
J ul y 4.  P MI D: 3 1 3 4 1 9 4 8. 
 
N ort o n J C, Sla wi ns ki P R, La y H S, Marti n J W, C o x B F, C u m mi ns G, Des m ulliez M P Y, 
Cl utt o n R E, O bstei n K L , C oc hra n S, Val dastri P.  I ntelli ge nt ma g netic ma ni p ulati o n f or 
gastr oi ntesti nal ultras o u n d.  Sci R o b ot. 2 0 1 9; 4( 3 1).  E p u b 2 0 1 9 J u n 1 9.  P MI D: 3 1 3 8 0 5 0 1. 
 
Bar d ucci L, Pitti gli o G, N ort o n J C, O bstei n K L , Val dastri P.  A da pti ve d y na mic c o ntr ol f or 
ma g neticall y act uate d me dical r o b ots.  I E E E R o b ot A ut o m Lett. 2 0 1 9; 4( 4): 3 6 3 3- 3 6 4 0.  E p u b 
2 0 1 9 J ul 1 5.  P MI D: 3 1 4 0 6 9 1 5. 
 
Gar bi n N, Ma m u nes A P, S o h n D, Ha w ki ns R W, Val dastri P, O bstei n K L .  E val uati o n of a 
n o vel l o w-c ost dis p osa ble e n d osc o pe f or vis ual assess me nt of t he es o p ha g us a n d st o mac h i n a n 
e x- vi v o p ha nt o m m o del.  E n d osc o p y I nter nati o nal O pe n. 2 0 1 9; 7( 9): E 1 1 7 5- E 1 1 8 3.  E p u b 2 0 1 9 
A u g 2 9.  P MI D: 3 1 4 7 5 2 3 7. 
 
Cal ò S, C ha n dler J, Ca m pisa n o F, O bstei n K L , Val dastri P.  A c o m pressi o n val ve f or sa nitar y 
c o ntr ol of fl ui d dri ve n act uat ors.  I E E E/ A S M E Tra ns Mec hatr o nics. 2 0 2 0; 2 5( 2): 1 0 0 5- 1 0 1 5.  
E p u b 2 0 1 9 Dec 1 7.  P MI D: 3 2 3 5 5 4 4 0.  D OI: 1 0. 1 1 0 9/ T M E C H. 2 0 1 9. 2 9 6 0 3 0 8. 
 
Ca m pisa n o F, Re mirez A, Cal ò S, C ha n dler J H, O bstei n K L , We bster III RJ, Val dastri P.  
O nli ne dist ur ba nce esti mati o n f or i m pr o vi n g ki ne matic acc urac y i n c o nti n u u m ma ni p ulat ors.  
I E E E R o b ot A ut o m Lett. 2 0 1 9; 4( 4): 3 6 3 3- 3 6 4 0.  E p u b 2 0 2 0 Fe b 1 0.  P MI D: 3 2 1 2 3 7 5 1.  D OI: 
1 0. 1 1 0 9/ L R A. 2 0 2 0. 2 9 7 2 8 8 0. 
 
Orr J, L oc k w o o d R, Ga m b oa A, Sla u g hter J C, O bstei n K L , Yac hi ms ki P.  E nteral ste nts f or 
mali g na nt gastric o utlet o bstr ucti o n: L o w rei nter ve nti o n rates f or o bstr ucti o n d ue t o pa ncreatic 

2 1  
 
a de n ocarci n o ma vers us ot her eti ol o gies.  J Gastr oi ntest S ur g.  E p u b 2 0 2 0 Fe b 1 9.  P MI D: 
3 2 0 7 7 0 4 5.  D OI: 1 0. 1 0 0 7/s 1 1 6 0 5- 0 1 9- 0 4 5 1 2- 6. 
 
Ya c hi ms ki P, La n de wee C A, Ca m pisa n o F, Val dastri P, O bstei n K L .  Waterjet Necr osect o m y 
de vice ( W A N D) f or e n d osc o pic ma na ge me nt of pa ncreatic necr osis: desi g n, de vel o p me nt, a n d 
precli nical testi n g ( wit h vi de os).  Gastr oi ntest E n d osc.  2 0 2 0; 9 2( 3): 7 7 0- 7 7 5.  E p u b 2 0 2 0 A pr 
2 2.  P MI D: 3 2 3 3 4 0 1 8.  D OI: 1 0. 1 0 1 6/j. gie. 2 0 2 0. 0 4. 0 2 4.  
 
C ha n dler J H, C ha u ha n M, Gar bi n N, O bstei n K L , Val dastri P.  Parallel heli x act uat ors f or s oft 
r o b otic a p plicati o ns.  Fr o nt R o b ot AI.  E p u b 2 0 2 0 J ul 2 9.  P MI D: 3 3 5 0 1 2 8 5.  DI O: 
1 0. 3 3 8 9/fr o bt. 2 0 2 0. 0 0 1 1 9.   
 
Ca m pisa n o F, Re mirez A, La n de wee C A, Cal ò S, O bstei n K L , We bster III RJ, Val dastri P.  
Tele o perati o n a n d c o ntact detecti o n of a waterjet-act uate d s oft c o nti n u u m ma ni p ulat or f or l o w-
c ost gastr osc o p y.  O nli ne dist ur ba nce esti mati o n f or i m pr o vi n g ki ne matic acc urac y i n 
c o nti n u u m ma ni p ulat ors.  I E E E R o b ot A ut o m Lett.  E p u b 2 0 2 0 A u g 4.  D OI: 
1 0. 1 1 0 9/ L R A. 2 0 2 0. 3 0 1 3 9 0 0. 
 
Rice S C, Sla u g hter J C, S malle y W E, O bstei n K L .  T he i m pact of distracti o n mi ni mizati o n o n 
e n d osc o pic me nt ori n g a n d perf or ma nce.  E n d osc o p y I nter nati o nal O pe n. 2 0 2 0; 8( 1 2): E 1 8 0 4-
E 1 8 1 0.  E p u b 2 0 2 0 N o v 1 7.  P MI D: 3 3 2 6 9 3 1 3. 
 
Marti n J W, Sca gli o ni B, N ort o n J C, S u bra ma nia n V, Arezz o A, O bstei n K L , Val dastri P.  
E na bli n g t he f ut ure of c ol o n osc o p y wit h i ntelli ge nt a n d a ut o n o m o us ma g netic ma ni p ulati o n.  
Nat ure Mac hi ne I ntelli ge nce. 2 0 2 0; 2( 1 0): 5 9 5- 6 0 6.  E p u b 2 0 2 0 Oct 1 2.  P MI D: 3 3 0 8 9 0 7 1. 
 
Me yers M H, Mai n MJ, Orr J K, O bstei n K L .  A case of C O VI D- 1 9-i n d uce d ac ute pa ncreatitis.  
Pa ncreas.  2 0 2 0 N o v/ Dec. 4 9( 1 0):e 1 0 8-e 1 0 9.  P MI D: 3 3 1 2 2 5 3 8.  D OI: 
1 0. 1 0 9 7/ M P A. 0 0 0 0 0 0 0 0 0 0 0 0 1 6 9 6. 
 
Ma m u nes A P, Ca m pisa n o F, Marti n J W, Sca gli o ni B, Maz o me n os E, Val dastri P, O bstei n 
K L .  Ma g netic fle xi ble e n d osc o pe f or c ol o n osc o p y: a n i nitial lear ni n g c ur ve a nal ysis.  E n d osc 
I nt O pe n.  2 0 2 1; 9( 2): E 1 7 1- E 1 8 0.  E p u b 2 0 2 1 Ja n 2 5.  P MI D: 3 3 5 3 2 5 5 5.  D OI: 1 0. 1 0 5 5/a-
1 3 1 4- 9 8 6 0. 
 
O naiza h O, K osz o ws ka Z, Wi nters C, S u bra ma nia n V, Ja y ne D, Arezz o A, O bstei n K L, 
Val dastri P.  G ui deli nes f or r o b otic fle xi ble e n d osc o p y at t he ti me of C O VI D- 1 9.  Fr o nt R o b ot 
AI.  2 0 2 1; 8: 6 1 2 8 5 2.  E p u b 2 0 2 1 Fe b 2 5.  P MI D: 3 3 7 1 8 4 3 9.  D OI: 1 0. 3 3 8 9/fr o bt. 2 0 2 1. 6 1 2 8 5 2. 
 
C ha u ha n M, C ha n dler J H, J ha A, S u bra ma nia n V, O bstei n K L, Val dastri P.  A n ori ga mi-
base d s oft r o b otic act uat or f or u p per gastr oi ntesti nal e n d osc o pic a p plicati o ns.  Fr o nt R o b ot AI. 
2 0 2 1; 8: 6 6 4 7 2 0.  P MI D: 3 4 0 4 1 2 7 5.  D OI: 1 0. 3 3 8 9/fr o bt. 2 0 2 1. 6 6 4 7 2 0. 
 
Ca m pisa n o F, Cal ó S, Re mirez A A, C ha n dler J H, O bstei n K L , We bster III RJ, Val dastri P.  
Cl ose d-l o o p c o ntr ol of s oft c o nti n u u m ma ni p ulat ors u n der ti p f oll o wer act uati o n.  I nt J R o b 
Res. 2 0 2 1; 4 0: 9 2 3- 9 3 8.  E p u b 2 0 2 1 Mar 1 5.  P MI D: 3 4 3 3 4 8 7 7. 
 

2 2  
 
Ma m u nes A P, P ora y k o M K, O bstei n K L .  All tie d u p: n ot y o ur t y pical diste n de d a b d o me n.  
Gastr oe nter ol o g y. E p u b 2 0 2 1 A u g 2 7.  D OI: 1 0. 1 0 5 3/j. gastr o. 2 0 2 1. 0 8. 0 4 9. 
 
S ha h BJ, O n ke n J E, E d gar L, J o u J H, O bstei n K L , Par di D S, Ric hter S, Re d d y G, R ose S, 
Sz yj k o ws ki R, Fi x O K.  De vel o p me nt of gastr oe nter ol o g y a n d tra ns pla nt he pat ol o g y 
milest o nes 2. 0: a g ui de f or pr o gra ms, fac ult y, a n d fell o ws.  A m J Gastr oe nter ol 
2 0 2 1; 1 1 6( 1 0): 2 0 0 9- 2 0 1 3.  E p u b 2 0 2 1 Se p 7.  P MI D: 3 4 4 9 1 2 3 3.  D OI: 
1 0. 1 4 3 0 9/aj g. 0 0 0 0 0 0 0 0 0 0 0 0 1 4 9 0. 
 
S ha h BJ, O n ke n J E, E d gar L, J o u J H, O bstei n K L , Par di D S, Ric hter S, Re d d y G, R ose S, 
Sz yj k o ws ki R, Fi x O K.  De vel o p me nt of gastr oe nter ol o g y a n d tra ns pla nt he pat ol o g y 
milest o nes 2. 0: a g ui de f or pr o gra ms, fac ult y, a n d fell o ws.  He pat ol o g y 2 0 2 1; 7 4( 4): 2 2 2 6- 2 2 3 2.  
E p u b 2 0 2 1 Se p 7.  P MI D: 3 4 4 9 1 5 8 3.  D OI: 1 0. 1 0 0 2/ he p. 3 2 0 9 7. 
 
S ha h BJ, O n ke n J E, E d gar L, J o u J H, O bste i n K L , Par di D S, Ric hter S, Re d d y G, R ose S, 
Sz yj k o ws ki R, Fi x O K.  De vel o p me nt of gastr oe nter ol o g y a n d tra ns pla nt he pat ol o g y 
milest o nes 2. 0: a g ui de f or pr o gra ms, fac ult y, a n d fell o ws.  Gastr oi ntest E n d osc 
2 0 2 1; 9 4( 4): 6 6 5- 6 7 0.  E p u b 2 0 2 1 Se p 7.  P MI D: 3 4 5 0 7 8 0 6.  D OI: 1 0. 1 0 1 6/j. gie. 2 0 2 1. 0 4. 2 0 1 9. 
 
S ha h BJ, O n ke n J E, E d gar L, J o u J H, O bstei n K L , Par di D S, Ric hter S, Re d d y G, R ose S, 
Sz yj k o ws ki R, Fi x O K.  De vel o p me nt of gastr oe nter ol o g y a n d tra ns pla nt he pat ol o g y 
milest o nes 2. 0: a g ui de f or pr o gra ms, fac ult y, a n d fell o ws.  Gastr oe nter ol o g y 
2 0 2 1; 1 6 1( 4): 1 3 1 8- 1 3 2 4.  E p u b 2 0 2 1 Se p 7.  P MI D: 3 4 5 0 7 8 0 7  D OI: 
1 0. 1 0 5 3/j. gastr o. 2 0 2 1. 0 7/ 0 4 0. 
 
T o m bazzi C, H o we C F, Sla u g hter J C, O bstei n K L .  Rates a n d fact ors ass ociate d wit h 
palliati ve care referral a m o n g patie nts decli ne d f or li ver tra ns pla ntati o n.  J Palliati ve Me d. 
E p u b 2 0 2 2 Mar 2 5.  D OI: 1 0. 1 0 8 9/j p m. 2 0 2 1. 0 4 0 3 
 
Bar d ucci L, Sca gli o ni B, Marti n J W, O bstei n K L , Val dastri P.  Acti ve sta bilizati o n of 
i nter ve nti o nal tas ks utilizi n g a ma g neticall y ma ni p ulate d e n d osc o pe.  Fr o nt R o b ot AI.  E p u b 
2 0 2 2, A pr 1 4.  D OI: 1 0. 3 3 8 9/fr o bt. 2 0 2 2. 8 5 4 0 8 1. 
 
 
 
A bstr acts: 
O bstei n K L , Fis h ki n Z, Zi v I.  T he Effect of Tita ni u m o n C o m p ute d T o m o gra p h y 
Meas ure me nts of B o ne Mi neral De nsit y.  Tra nsacti o ns of t he a n n ual meeti n g of t he 
Ort h o pae dic Researc h S ociet y. 1 9 9 8; 4 4: 4 1 4. 
  
O bstei n K L , Ca m p bell M S, Re d d y K R, Ya n g Y X.  Ass ociati o n of Pr ot o n P u m p I n hi bit or 
T hera p y wit h S p o nta ne o us Bacterial Perit o nitis.  Di gesti ve Disease Wee k, Ma y 2 0 0 6. 
 
O bstei n K L , Ca m p bell M S, Re d d y K R, Ya n g Y X.  Ass ociati o n of M o del f or E n d- Sta ge Li ver 
Disease ( M E L D) sc ore wit h S p o nta ne o us Bacterial Perit o nitis.  Di gesti ve Disease Wee k, Ma y 
2 0 0 7. 
  

2 3  
 
R y o u M K, E wers R, O bstei n K L , Ca ntill o n- M ur p h y P, R ya n M B, T h o m ps o n C C.  E val uati n g 
F orce i n N O T E S S ur ger y: a C o m paris o n of Pr o xi mal a n d Distal P us h, P ull, a n d T or q ue F orces 
i n a S pecific S ha pel oc ki n g E n d os ur gical Platf or m Vers us a Fle xi ble E n d osc o pe.  Di gesti ve 
Disease Wee k, J u ne 2 0 0 9. 
  
R y o u M K, O bstei n K L , Carr- L oc ke D L, R ya n M B, T h o m ps o n C C.  A N o vel S piral O vert u be 
f or E val uati n g t he Pa ncreatic o biliar y Li m b a n d Def u ncti o nalize d St o mac h i n R o u x-e n-Y 
Gastric B y pass Patie nts.  Di gesti ve Disease Wee k, J u ne 2 0 0 9. 
  
R y o u M K, Di Mai o CJ, M ulla d y D, O bstei n K L , S wa ns o n R S, Carr- L oc ke D, T h o m ps o n C C.  
E U S - Assiste d Pa ncreatic A nte gra de Nee dle- K nife ( P A N K) f or Treat me nt of S y m pt o matic 
Pa ncreatic D uct Dilati o n I naccessi ble t o Tra ns pa pillar y E n d osc o pic T hera p y: A N o vel 
Tec h ni q ue i n a Case Series of F o ur Patie nts.  Di gesti ve Disease Wee k, J u ne 2 0 0 9. 
 
O bstei n K L , Gree n walt I T, S hai k h S N, R y o u M K, R ya n M B, T h o m ps o n C C.  P u blic 
Perce pti o n of O besit y I nter ve nti o ns: A S ur ve y of O pi ni o ns Re gar di n g S ur gical a n d Pri mar y 
E n d ol u mi nal Tec h ni q ues.  T he A merica n C olle ge of Gastr oe nter ol o g y A n n ual Meeti n g, 
Oct o ber 2 0 0 9. 
  
O b stei n K L, Kee ga n BJ, R y o u M K, Lee L S, T h o m ps o n C C.  Safet y of I ntra ve n o us (I V) 
C o nsci o us Se dati o n S u p p orte d E n d osc o p y i n Patie nts wit h a Hist or y of Gastric B y pass.  T he 
A merica n C olle ge of Gastr oe nter ol o g y A n n ual Meeti n g, Oct o ber 2 0 0 9. 
 
R y o u M K, Ne mir os ki A, Aza g ur y D E, S hai k S N, R ya n M B, O bstei n K L , Wester velt R M, 
T h o m ps o n C C.  Wireless Bi ose nsi n g of L o wer Gastr oi ntesti nal Blee di n g a n d Occ ult 
Gastr oi ntesti nal Blee di n g: A Para di g m S hift i n Dia g n osis a n d Treat me nt.  Di gesti ve Disease 
Wee k, Ma y 2 0 1 0. 
  
R y o u M K, S hai k S N, R ya n M B, O bstei n K L , D uc k o C T, V os b ur g h K G, T h o m ps o n C C.  
Tra ns- Es o p ha geal N O T E S S ur ger y i n a H u ma n Ca da veric M o del A u g me nte d b y a Real- Ti me 
T hree Di me nsi o nal C T G ui da nce S yste m.  Di gesti ve Disease Wee k, Ma y 2 0 1 0. 
 
C ha n W W, C hi o u E, O bs tei n K L, Ti g n or A S, W hitl oc k T L.  T he Efficac y of Pr ot o n P u m p 
I n hi bit ors f or Treat me nt of Ast h ma: A Meta- A nal ysis.  Di gesti ve Disease Wee k, Ma y 2 0 1 0. 
  
O bstei n K L , T h o m ps o n C C, Ma urice D, Matt hes E L, Carr- L oc ke D L.  M uc osal Ele vati o n i n 
H u ma n S u bjects utilizi n g a n o vel Ha n d- Hel d Nee dle-less S yste m.  Di gesti ve Disease Wee k, 
Ma y 2 0 1 0. 
  
O bstei n K L , Sa n J osé- Esté par R, Ja ye n der J, Patil V D, S p off or d I S, R ya n M B, Le n g yel BI, 
S ha ms R, V os b ur g h K G, T h o m ps o n C C.  E val uati o n of I ma ge Re gistere d Gastr osc o pic 
Ultras o u n d (I R G U S) i n H u ma n S u bjects.  Di gesti ve Disease Wee k, Ma y 2 0 1 0. 
  
S p off or d I S, K u mar N, O bstei n K L , Le n g yel BI, Ja ga deesa n J, V os b ur g h K G, T h o m ps o n C C.  
Dec o nstr ucti n g t he C ol o n osc o pic E xa mi nati o n: Preli mi nar y res ults c o m pari n g e x pert a n d 
n o vice ki ne matic pr ofiles i n scree ni n g c ol o n osc o p y.  Di gesti ve Disease Wee k, Ma y 2 0 1 0. 
 

2 4  
 
L o W, O bstei n K L , C ha n W W.  Pr ot o n P u m p I n hi bit or Use a n d t he Ris k of B o ne Fract ure: A 
Meta -a nal ysis.  Di gesti ve Disease Wee k, Ma y 2 0 1 1. 
  
O bstei n K L , O n g R, Gall o wa y R L.  C o nfir mati o n of Ki ne matic Pri nci ples i n t he E val uati o n of 
C ol o n osc o p y Tec h nical S kill Le vel.  T he A merica n C olle ge of Gastr oe nter ol o g y A n n ual 
Meeti n g, Oct o ber 2 0 1 1. 
  
Sc hi n dler A E, C ha n W W, O bstei n K L .  Relia bilit y of t he B ost o n B o wel Pre parati o n Scale i n 
t he e n d osc o p y n urse p o p ulati o n.  Di gesti ve Disease Wee k, Ma y 2 0 1 2. 
 
Sc hi n dler A E, C ha n W W, R y o u M K, O bstei n K L .  Patie nt u n dersta n di n g of b o wel 
pre parati o n i nstr ucti o ns directl y c orrelates wit h q ualit y of c ol o n osc o p y.  Di gesti ve Disease 
Wee k, Ma y 2 0 1 2.  
  
Sc hi n dler A E, C ha n W W, R y o u M K, O bstei n K L .  S plit- d ose p ol yet h yle ne gl yc ol ( P E G)-
base d b o wel pre parati o n f or after n o o n c ol o n osc o p y i m pr o ves pre parati o n q ualit y o ver si n gle-
d ose P E G- base d pre parati o n i n t he e ve ni n g bef ore c ol o n osc o p y.  Di gesti ve Disease Wee k, 
Ma y 2 0 1 2.   
  
O bstei n K L , O n g R, Sla u g hter J C, Gall o wa y R L.  Pre dicti n g E n d osc o pist Tec h nical S kill 
Le vel Utilizi n g Ki ne matic Data.  Di gesti ve Disease Wee k, Ma y 2 0 1 2. 
 
O bstei n K L , C ha n W W, Gall o wa y R L.  Virt ual vis ualizati o n of c ol o n osc o pe p ositi o n d uri n g 
e n d osc o p y re d uces n o vice trai nees percei ve d le vel of diffic ult y.  Di gesti ve Disease Wee k, Ma y 
2 0 1 2.  
 
Di Natali C, Becca ni M, O bstei n K L , Val dastri P.  Wireless real-ti me p ose detecti o n f or 
ma g netic ma ni p ulate d e n d osc o pic ca ps ules.  Di gesti ve Disease Wee k, Ma y 2 0 1 3. 
 
Bell C S, Val dastri P, O bstei n K L .  P ose esti mati o n f or r o b ot c o ntr olle d ma g netic e n d osc o pe 
tele o perati o n.  Di gesti ve Disease Wee k, Ma y 2 0 1 3.  
 
 
O bstei n K L , S mit h B, Fa n g B, Pasric ha T, Ger di n g J S, Val dastri P.  I n viv o c ol o nic 
i ns ufflati o n via a wireless ca ps ule s yste m.  Di gesti ve Disease Wee k, Ma y 2 0 1 3. 
 
O bstei n K L , Ca prara RJ, Di Natali C, Becca ni M, Sc ozzarr o G, M or ga n D R, Val dastri P.  
Ultra l o w-c ost e n d osc o p y f or gastric ca ncer scree ni n g i n l o w res o urce setti n gs.  Di gesti ve 
Disease Wee k, Ma y 2 0 1 4.  
 
Bell C S, O bstei n K L , Val dastri P.  Wireless ta blet a p plicati o n f or re m ote c olla b orati o n a n d 
trai ni n g i n c ol o n osc o p y.  Di gesti ve Disease Wee k, Ma y 2 0 1 4.  
 
Ji m o h L Y, O bstei n K L .  I m pact of a n o vel m o bile de vice a p plicati o n f or e n d osc o pic 
pr oce d ure l o g gi n g.  T he A merica n C olle ge of Gastr oe nter ol o g y A n n ual Meeti n g, Oct o ber 
2 0 1 4. 
 

2 5  
 
Ta d dese A Z, Sla wi ns ki P R, M ust o K B, Val dastri P, O bstei n K L .  E val uati o n of a n o vel 
ma g netic act uate d ca ps ule e n d osc o pe f or c ol orectal ca ncer scree ni n g: a preli mi nar y feasi bilit y 
st u d y.  Di gesti ve Disease Wee k, Ma y 2 0 1 6.  
 
Rice S C, Hi g gi n b ot ha m T, Dea n MJ, Sla u g hter J C, Yac hi ms ki P S, O bstei n K L . 
C o m pre he nsi ve patie nt e d ucati o n o n diet pri or t o o ut patie nt c ol o n osc o p y d oes n ot i m pr o ve 
q ualit y of b o wel pre parati o n: A pr os pecti ve, ra n d o mize d, c o ntr olle d trial.  Di gesti ve Disease 
Wee k, Ma y 2 0 1 6. 
 
Gar bi n N, Sar ker S, S o h n D, Sla wi ns ki P R, Val dastri P, O bstei n K L .  E val uati o n of a n o vel 
dis p osa ble u p per e n d osc o pe f or u nse date d be dsi de ( n o n-e n d osc o p y u nit base d) assess me nt of 
t he u p per gastr oi ntesti nal ( U GI) tract.  Di gesti ve Disease Wee k, Ma y 2 0 1 7.  
 
Sar ker S, Sla wi ns ki P R, Ta d dese A Z, M ust o K B, Val dastri P, O bstei n K L .  T he first 
a ut o n o m o usl y c o ntr olle d ca ps ule r o b ot f or c ol o n e x pl orati o n.  Di gesti ve Disease Wee k, Ma y 
2 0 1 7.  
 
Raja g o pala n S, Rice S C, Sla wi ns ki P R, Val dastri P, O bstei n K L .  E val uati o n of a n a ut o mate d 
lesi o n detecti o n platf or m f or wireless ca ps ule e n d osc o p y: a n o vel a p pr oac h utilizi n g vi de o-
base d mac hi ne lear ni n g te m p oral relati o ns hi ps.  Di gesti ve Disease Wee k, Ma y 2 0 1 9.  
 
Orr J, L oc k w o o d R, Ga m b oa A, Sla u g hter J C, O bstei n K L , Yac hi ms ki P.  E nteral ste nts f or 
mali g na nt gastric o utlet o bstr ucti o n: l o w rei nter ve nti o n rates f or o bstr ucti o n d ue t o pa ncreatic 
d uctal a de n ocarci n o ma vers us ot her mali g na nt eti ol o gies.  Di gesti ve Disease Wee k, Ma y 2 0 1 9.  
 
C ha n dler J H, C ha u ha n M, Cal ò S, Ar u para yil N, Gar bi n N, Ca m pisa n o F, O bstei n K L , 
Val dastri P.  Usa bilit y of a n o vel dis p osa ble e n d osc o pe f or gastric ca ncer scree ni n g i n l o w-
res o urce setti n gs: Res ults fr o m r ural I n dia.  Di gesti ve Disease Wee k, Ma y 2 0 2 0.  P oster of 
Disti ncti o n.  ( C o nfere nce Ca ncele d) 
 
Sa n d o val G, O bstei n K L .  Dis parities i n healt h: L o wer c ol orectal ca ncer scree ni n g rates 
a m o n g L G B T Q patie nts.  Di gesti ve Disease Wee k, Ma y 2 0 2 0.  ( C o nfere nce Ca ncele d) 
 
Rice S C, Sla u g hter J C, S malle y W E, O bstei n K L .  T he i m pact of distracti o n mi ni mizati o n o n 
e n d osc o pic me nt ori n g a n d perf or ma nce.  Di gesti ve Disease Wee k, Ma y 2 0 2 0.  ( C o nfere nce 
Ca ncele d) 
 
Ma m u nes A, Ca m pisa n o F, Marti n J W, Sca gli o ni B, Maz o me n os E, Val dastri P, O bst ei n K L.  
T he Ma g netic Fle xi ble E n d osc o pe ( M F E): A lear ni n g c ur ve a nal ysis.  Di gesti ve Disease 
Wee k, Ma y 2 0 2 0.  ( C o nfere nce Ca ncele d) 
 
T o m bazzi C, H o we C F, Sla u g hter J C, O bstei n K L .  L o w palliati ve care referral rates a m o n g 
patie nts decli ne d f or li ver tra ns pla nt.  Di gesti ve Disease Wee k, Ma y 2 0 2 1. 
 
Marti n J W, Bar d ucci L, Sca gli o ni B, N ort o n J C, Val dastri P, O bstei n K L .  A ut o n o m o us 
r o b otic bi o ps y f or c ol o n osc o p y: a feasi bilit y st u d y.  Di gesti ve Disease Wee k, Ma y 2 0 2 2. 
 
 

2 6  
 
  
Te xt b o o k C h a pters:  
Ja ye n der J, Sa n J osé- Esté par R, O bstei n K L , Patil V D, T h o m ps o n C C, V os b ur g h K G.  Hi d de n 
Mar k o v M o del f or Q ua ntif yi n g Cli nicia n E x pertise i n Fle xi ble I nstr u me nt Ma ni p ulati o n.  I n 
H Lia o, P E d war ds, X Pa n, Y Fa n, G Z Ya n g, e ds., Me dical I ma gi n g a n d A u g me nte d Realit y, 
v ol u me 6 3 2 6 of Lect ure N otes i n C o m p uter Scie nce.  S pri n ger, 2 0 1 0; 3 6 3- 3 7 2. 
 
Sla wi ns ki P R, Ta d dese A Z, O bstei n K L , Val dastri P.  C ha pter 1 7: R o b otic ca ps ule e n d osc o p y. 
Desai J P, Patel R, Ferreira A, A gra wal S, e ds., T he E n c ycl o pe dia of Me dical R o b otics.  W orl d 
Scie ntific P u b C o I nc, 2 0 1 8. 
 
Nai k R, O bstei n K L .  Tra u ma a n d f orei g n b o dies.  Dia g n osis a n d ma na ge me nt g ui de f or a n o-    
rectal disease: a cli nical refere nce. Q ueres hi W A, e d., Slac k I nc, 2 0 1 9.  I S B N- 1 0: 1 6 3 0 9 1 4 9 2 4. 
 
Patel D, O bstei n K L .  Nas o gastric a n d Nas oe nteric t u bes ( d u o de nal a n d jej u nal).  Ha n d b o o k of 
Gastr oe nter ol o gic Pr oce d ures, 5 t h e diti o n.  La w R, Bar o n T H, e ds., W olters Kl u wer, 2 0 2 0.  
I S B N- 1 0: 1 9 7 5 1 1 1 6 5 6; I S B N- 1 3: 9 7 8- 1 9 7 5 1 1 1 6 5 6. 
 
 
Prese nt ati o ns: 
O bstei n K L , Ki ms ma G K ( prese nter), C ha m bers T.  Ei n h u ma nes E n de? Ster be hilfe i n de n 
Nie derla n de n u n d i n De utsc hla n d i m Ver gleic h ( C o m pari n g hel pi n g t o die i n t he Net herla n ds 
a n d Ger ma n y), E x perie nces a n d O bser vati o ns fr o m t he Me dical Practice i n Hel pi n g Pe o ple 
Die.  Prese nte d i n M u nster, Ger ma n y, Marc h 2 0 0 3. 
  
O bstei n K L  ( Prese nter), Da nc kers U, Halstea d J, Si m ps o n D.  A Ri g ht t o Die: Pers pecti ves o n 
E ut ha nasia a n d P h ysicia n- Assiste d S uici de.  Prese nte d i n C hica g o, I L at De Pa ul U ni versit y 
Sc h o ol f or Ne w Lear ni n g, Ja n uar y 2 0 0 4.  
  
Va n Lee we n E, Jac ks o n A, O bstei n K L  ( Prese nter), Clar k C C, Va n Baarse n B.  Ore g o n a n d 
T he Net herla n ds o n P h ysicia n- Assiste d D yi n g: E m pirical Data, C o nce pt ual Iss ues, a n d 
De vel o p me nts i n J ustificati o n.  Prese nte d at t he a n n ual meeti n g of t he A merica n S ociet y f or 
Bi oet hics a n d H u ma nities, Oct o ber 2 0 0 4. 
  
S hi h G ( prese nter), O bstei n K L , J o h ns o n J, Ya n g Y X.  C ol orectal Ca ncer Scree ni n g 
C ol o n osc o p y i n El derl y Patie nts wit h De me ntia: A Decisi o n A nal ysis.  Prese nte d at Di gesti ve 
Disease Wee k, Ma y 2 0 0 6. 
  
Ne mir os ki A ( prese nter), Br o w n K, Issa d ore D, Wester velt R, T h o m ps o n C C, O bstei n K L , 
Lai ne M.  Mi niat ure Wireless Bi o Se ns or f or Re m ote E n d osc o pic M o nit ori n g.  Prese nte d at t he 
A merica n P h ysics S ociet y Meeti n g, Marc h 2 0 0 9. 
  
Fer ná n dez- Es parrac h G ( Prese nter), O bstei n K L , Marti ns F P, R y o u M K, T h o m ps o n C C.  
Utili da d de u n p oli mer o ter m ose nsi ble e n la ne ur olisis del ple x o celiac o g uia da p or use: 
e x perie ncia i nicial e n u n m o del o p orci n o.  Prese nte d i n Barcel o na, S pai n, N o ve m ber 2 0 0 9. 
  

2 7  
 
R y o u M K ( Prese nter), Ga n SI, Di Mai o CJ, M ulla d y D, O bstei n K L , R ya n M B, Carr- L oc ke D, 
T h o m ps o n C C.  A d va nce d E n d osc o pic Pa ncratic o biliar y T hera p y i n S ur gicall y- Altere d E nteral 
A nat o m y.  A S G E vi de o f or u m.  Di gesti ve Disease Wee k, J u ne 2 0 0 9. 
  
O bstei n K L  ( prese nter), Slatter y J, Carr- L oc ke D, T h o m ps o n C C.  E n d osc o pic Re pair of a 
T y pe II Paraes o p ha geal Her nia wit h Mese nter oa xial V ol v ul us.  A S G E vi de o f or u m.  Di gesti ve 
Disease Wee k, J u ne 2 0 0 9.    
  
Aza g ur y D E ( prese nter), R y o u M K, S hai k S N, Sa n J osé- Esté par R, R ya n M B, O bstei n K L , 
Le n g yel BI, Patil V D, Ja ye n der J, V os b ur g h K G, T h o m ps o n C C.  I ma ge Re gistrati o n i n 
N O T E S: Use of Real Ti me C T- base d A u g me nte d Realit y f or N O T E S Na vi gati o n a n d Ma p pi n g 
of O pti mal N O T E S Access Sites usi n g Ki ne matics i n H u ma n Ca da vers.  Di gesti ve Disease 
Wee k, Ma y 2 0 1 0. 
  
R y o u M K ( prese nter), Ne mir os ki A, Aza g ur y D E, S hai k S N, R ya n M B, O bstei n K L , 
Wester velt R M, T h o m ps o n C C.  Wireless Bi ose nsi n g of U p per Gastr oi ntesti nal Blee di n g: A 
Para di g m S hift i n Dia g n osis a n d Treat me nt.  Di gesti ve Disease Wee k, Ma y 2 0 1 0. 
  
O bstei n K L  ( prese nter), Ja ye n der J, Patil V D, Sa n J osé- Esté par R, S p off or d I S, Le n g yel BI, 
R ya n M B, V os b ur g h K G, T h o m ps o n C C.  I ma ge G ui de d Tec h n ol o g y i n E n d osc o p y.  A S G E 
vi de o f or u m.  Di gesti ve Disease Wee k, Ma y 2 0 1 0. 
  
O bstei n K L  ( prese nter).  I ma ge G ui de d Tec h n ol o g y i n E n d osc o p y.  Ne w E n gla n d E n d osc o p y 
S ociet y, Ma y 2 0 1 0.  
 
Ja ye n der J ( prese nter), Sa n J osé- Esté par R, O bstei n K L , Patil V D, T h o m ps o n C C, V os b ur g h 
K G.  Hi d de n Mar k o v M o del f or Q ua ntif yi n g Cli nicia n E x pertise i n Fle xi ble I nstr u me nt 
Ma ni p ulati o n.  Prese nte d at Me dical I ma gi n g a n d A u g me nte d Realit y 2 0 1 0, Beiji n g, C hi na, 
Se pte m ber 2 0 1 0. 
  
O bstei n K L  ( prese nter).  Di vertic ular Disease of t he C ol o n.  Va n der bilt U ni versit y Me dical 
Ce nter, De part me nt of Me dici ne, I nter nal Me dici ne Resi de nc y C ore C urric ul u m C o nfere nce, 
Ja n uar y 2 0 1 1. 
  
O bstei n K L  ( prese nter).  C ol o n osc o p y Trai ni n g: Si m ulat ors, Ki ne matics, a n d 3 D Sca n ni n g —
O h M y!  Va n der bilt U ni versit y Me dical Ce nter, Gastr oe nter ol o g y Di visi o n Gra n d R o u n ds, 
Marc h 2 0 1 1. 
  
O bstei n K L ( prese nter).  S m o ot h M o ves: E val uati o n of C ol o n osc o p y Tec h nical S kill Le vel 
Utilizi n g Ki ne matic Data.  Va n der bilt U ni versit y E n gi neeri n g a n d S ur ger y Se mi nar Series, 
J u ne 2 0 1 1. 
  
O bstei n K L  ( prese nter).  Q ualit y C ol o n osc o p y.  Va n der bilt U ni versit y Me dical Ce nter 
Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, GI/ He pat ol o g y U p date 2 0 1 1, 
Se pte m ber 2 4, 2 0 1 1. 
  
O bstei n K L  ( prese nter).  Q ua ntitati ve Assess me nt of C ol o n osc o p y Tec h nical S kill Le vel.  
Va n der bilt U ni versit y Sc h o ol of E n gi neeri n g, Bi o me dical E n gi neeri n g Se mi nar, Se pte m ber 2 7, 
2 0 1 1.  

2 8  
 
  
O bstei n K L  ( prese nter).  Gastr oe nter ol o g y, E n gi neeri n g, a n d Q ualit y I m pr o ve me nt.  
Va n der bilt U ni versit y Me dical Ce nter Di visi o n of Gastr oe nter ol o g y, He pat ol o g y, a n d 
N utriti o n, Researc h Se mi nar, N o ve m ber 3, 2 0 1 2. 
  
O bstei n K L  ( prese nter).  E n d osc o pic q ualit y i m pr o ve me nt: W hat y o u nee d t o k n o w f or y o ur 
practice …  Va n der bilt U ni versit y Me dical Ce nter, Gastr oe nter ol o g y Di visi o n Gra n d R o u n ds, 
Ja n uar y 2 0 1 3. 
  
O bstei n K L  ( prese nter), Val dastri P.  E na bli n g tec h n ol o gies f or wireless ca ps ule c ol o n osc o p y: 
Is t his t he e n d of c ol o n osc o p y as we k n o w it? Vi S E Se mi nar Series, Va n der bilt U ni versit y 
Sc h o ol of E n gi neeri n g, Fe br uar y 7, 2 0 1 3. 
  
Becca ni M ( prese nter), Di Natali C, Val dastri P, O bstei n K L .  Rest ori n g tactile perce pti o n i n 
Nat ural Orifice Tra nsl u mi nal E n d osc o pic S ur ger y ( N O T E S) t hr o u g h wireless tiss ue pal pati o n.  
Di gesti ve Disease Wee k, Ma y 2 0 1 3. 
 
O bstei n K L  ( prese nter). T he dia g n osis a n d treat me nt of Gastr o paresis.  Va n der bilt U ni versit y 
Me dical Ce nter, Gastr oe nter ol o g y Di visi o n Gra n d R o u n ds, Ja n uar y 2 0 1 4. 
 
O bstei n K L  ( prese nter), Pasric ha T, Mitc hell V R, S mit h B F, Val dastri P.  I n viv o c ol o nic 
i ns ufflati o n via a dis p osa ble C O2 i ns ufflati o n s yste m.  Di gesti ve Disease Wee k, Ma y 2 0 1 4. 
 
Er ge n, W F ( prese nter), Pasric ha T, Hi g gi n b ot ha m T, H u b bar d FJ, Sla u g hter J C, O bstei n K L.  
Use of a n e d ucati o nal b o o klet i m pr o ves t he q ualit y of i n patie nt c ol o n osc o p y b o wel 
pre parati o n: res ults of a pr os pecti ve ra n d o mize d c o ntr olle d trial.  Di gesti ve Disease Wee k, 
Ma y 2 0 1 4. 
 
O bstei n K L  ( prese nter).  Micr osc o pic C olitis.  Va n der bilt U ni versit y Me dical Ce nter Di visi o n 
of Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, GI/ He pat ol o g y U p date 2 0 1 4, Se pte m ber 2 6, 
2 0 1 4. 
 
O bstei n K L  ( prese nter).  C urre nt iss ues a n d f ut ure de vel o p me nts i n ca ps ule e n d osc o p y.  
Va n der bilt U ni versit y Me dical Ce nter De part me nt of Me dici ne, Me dici ne Gra n d R o u n ds, 
A pril 2 3, 2 0 1 5. 
 
La b or de C ( prese nter), Bell C S, Sla u g hter J C, Val dastri P, O bstei n K L.  
E val uati o n of a n o vel ta blet a p plicati o n f or i m pr o ve me nt i n c ol o n osc o p y trai ni n g a n d p ol y p 
i de ntificati o n.  Di gesti ve Disease Wee k, Ma y 2 0 1 5. 
 
O bstei n K L  ( prese nter).  “ O n-call” e mer ge ncies.  Di gesti ve Disease Wee k, Ma y 2 0 1 5.  
 
O bstei n K L  ( prese nter).  Meas ures t o i m pr o ve y o ur A de n o ma Detecti o n Rate.  Va n der bilt 
U n i versit y Me dical Ce nter Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, 
GI/ He pat ol o g y U p date 2 0 1 5, Se pte m ber 2 5, 2 0 1 5. 
 

2 9  
 
O b stei n K L ( prese nter).  Micr osc o pic C olitis--- U p date 2 0 1 6.  Va n der bilt U ni versit y Me dical 
Ce nter Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, GI/ He pat ol o g y U p date 2 0 1 6, 
Se pte m ber 2 3, 2 0 1 6. 
 
O bstei n K L  ( prese nter). U p date: Gastr o paresis.  Va n der bilt U ni versit y Me dical Ce nter, 
Gastr oe nter ol o g y Di visi o n Gra n d R o u n ds, Fe br uar y 2 0 1 7. 
 
Sla wi ns ki P R ( prese nter), Ta d dese A Z, M ust o K B, O bstei n K L , Val dastri P.  A ut o n o m o us 
retr ofle xi o n of a ma g netic fle xi ble e n d osc o pe.  I nter nati o nal C o nfere nce o n R o b otics a n d 
A ut o mati o n (I C R A), Si n ga p ore, Ma y 2 0 1 7. 
 
O bstei n K L  ( prese nter).  C urre nt iss ues a n d f ut ure de vel o p me nts i n ca ps ule e n d osc o p y.  
Tia nji n U ni versit y, Tia nji n, C hi na, C o nfere nce of Me dical R o b otics, Oct o ber, 2 0 1 7. 
 
O bstei n K L  ( prese nter).  G ot fee d bac k?  Va n der bilt U ni versit y Me dical Ce nter, 
Gastr oe nter ol o g y Di visi o n Gra n d R o u n ds, Dece m ber 2 0 1 7. 
 
O bstei n K L  ( prese nter).  P ol y pect o m y: C ol d or H ot?  I nstit ute f or Trai ni n g a n d Tec h n ol o g y, 
A merica n S ociet y f or Gastr oi ntesti nal E n d osc o p y, C ol o n osc o p y: Dia g n ostic t o T hera pe utic.  
A pril 2 0 1 8. 
 
Bar d ucci L ( prese nter), Pitti gli o G, Marti n J, N ort o n J C, O bstei n K L , A vizza n o C A, Val dastri 
P.  Gra vit y c o m pe nsati o n c o ntr ol f or ma g netic ca ps ule c ol o n osc o p y.  T he Ha ml y n S y m p osi u m 
o n Me dical R o b otics, L o n d o n, E n gla n d, J u ne 2 0 1 8. 
 
O bstei n K L  ( prese nter).  Gastr o paresis.  Va n der bilt U ni versit y Me dical Ce nter Di visi o n of 
Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, GI/ He pat ol o g y U p date 2 0 1 8, A u g ust 2 5, 2 0 1 8. 
 
Marti n J, Sca gli o ni B, Pitti gli o G, N ort o n J C, Sla wi ns ki P R, O bstei n K L  ( prese nter), Val dastri 
P.  I ma ge- g ui de d a ut o n o m o us c ol o n e x pl orati o n wit h a ma g netic fle xi ble e n d osc o pe.  Nati o nal 
I ma ge- G ui de d T hera p y W or ks h o p, B ost o n, M A, Oct o ber 2 0 1 8. 
 
Marti n J, Sca gli o ni B ( prese nter), N ort o n J, O bstei n K L , Val dastri P.  T o war d a ut o n o m o us 
r o b otic c ol o n osc o p y: m oti o n strate gies f or ma g netic ca ps ule na vi gati o n.  I E E E I ntl c o nfere nce 
o n c y b or g a n d bi o nic s yste ms ( C B S), S he nz he n, C hi na, Oct o ber 2 0 1 8. 
 
O bstei n K L  ( prese nter).  Tec h ni q ues a n d strate gies f or effecti ve s u per visi o n a n d i nstr ucti o n.  
I nstit ute f or Trai ni n g a n d Tec h n ol o g y, A merica n S ociet y f or Gastr oi ntesti nal E n d osc o p y, GI 
Or ga nizati o nal Lea ders hi p De vel o p me nt ( G O L D) pr o gra m, Fe br uar y 2 0 1 9. 
 
O bstei n K L  ( prese nter).  P ol y pect o m y: Pre ve nti o n/ Treat me nt of A d verse E ve nts.  I nstit ute f or 
Trai ni n g a n d Tec h n ol o g y, A merica n S ociet y f or Gastr oi ntesti nal E n d osc o p y, L o wer E M R 
S T A R pr o gra m, Fe br uar y 2 0 1 9. 
 
O bstei n K L  ( prese nter).  E n d osc o pic q ualit y i m pr o ve me nt.  Va n der bilt U ni versit y Me dical 
Ce nter, Gastr oe nter ol o g y Di visi o n Gra n d R o u n ds, Fe br uar y 2 0 1 9. 
 

3 0  
 
Marti n J W, Sla wi ns ki P R, Sca gli o ni B, N ort o n J C, Val dastri P, O bstei n K L ( prese nter).  
Assisti ve-a ut o n o m y i n c ol o n osc o p y: pr o p ulsi o n of a ma g netic fle xi ble e n d osc o pe.  Di gesti ve 
Disease Wee k, Ma y 2 0 1 9. 
 
O bstei n K L  ( prese nter).  P ol y pect o m y: H ot or C ol d?  Va n der bilt U ni versit y Me dical Ce nter 
Di visi o n of Gastr oe nter ol o g y, He pat ol o g y a n d N utriti o n, GI/ He pat ol o g y U p date 2 0 1 9, 
Se pte m ber 1 3, 2 0 1 9. 
 
La n de wee C A ( prese nter), Ca m pisa n o F, Yac hi ms ki P, Val dastri P, O bstei n K L .  T he 
Waterjet Necr osect o m y De vice ( W A N D): A n o vel i nstr u me nt f or ma na ge me nt of pa ncreatic 
necr osis.  Di gesti ve Disease Wee k, Ma y 2 0 2 0. ( C o nfere nce Ca ncele d; C O VI D- 1 9) 
 
O bstei n K L  ( prese nter).  N o vel a d va nces a n d f ut ure h oriz o ns i n dis p osa ble e n d osc o pes.  
Ass ociati o n of S ur gical Tec h n ol o gists ( A S T) Nati o nal C o nfere nce, Ma y 2 0 2 0. ( C o nfere nce 
Ca ncele d; C O VI D- 1 9) 
 
O bstei n K L  ( prese nter; h ost); Sal va d or S, M u njal A, Rice S C.  A S G E We bi nar: Pre pari n g a n d 
na vi gati n g a s uccessf ul c o urse t hr o u g h GI fell o ws hi p: a year- b y- year pers pecti ve.  J u ne 2 5, 
2 0 2 0. 
 
O bstei n K L  ( prese nter/ h ost); Prese nters/ Pa nelists: Ka ul V, Mc Gill S, Pare k h N.  A S G E 
We bi nar: C ol orectal ca ncer scree ni n g a n d s ur veilla nce.  Se pte m ber 1 7, 2 0 2 0. 
 
O bstei n K L  ( prese nter).  F orei g n b o d y e xtracti o n: U p a b o ve a n d d o w n bel o w.  S ociet y of 
Gastr oe nter ol o g y N urses a n d Ass ociates ( S G N A) A n n ual C o urse, Oct o ber 2 0 2 0. ( C o nfere nce 
O nli ne; C O VI D- 1 9) 
 
Tier ne y W ( h ost); Prese nters/ Pa nelists: A bra ha m B, Farra ye F, O bstei n K L .  A S G E We bi nar: 
T he i m pact of C O VI D- 1 9 o n GI practices.  Ja n uar y 2 7, 2 0 2 1. 
 
O bstei n K L  ( prese nter).  A S G E We bi nar: P ol y pect o m y – pre ve nti o n a n d treat me nt of a d verse 
e ve nts.  Fe br uar y 1 1, 2 0 2 1. 
 
O bstei n K L  ( prese nter).  Va n der bilt Pre- Healt h Pr ofessi o ns Lect ure Series: Gastr oe nter ol o g y 
1 0 1: c ore c o m pete nc y oral c o m m u nicati o n.  A pril 7, 2 0 2 1. 
 
O bstei n K L  ( prese nter).  Fee d bac k.  Va n der bilt U ni versit y Me dical Ce nter, Gastr oe nter ol o g y 
Di visi o n Gra n d R o u n ds, J u ne 1 7, 2 0 2 1. 
 
O bstei n K L  ( prese nter).  F orei g n b o d y e xtracti o n: U p a b o ve a n d d o w n bel o w.  S ociet y of 
Gastr oe nter ol o g y N urses a n d Ass ociates ( S G N A) A n n ual C o urse, Oct o ber 2 0 2 0. ( C o nfere nce 
O nli ne; C O VI D- 1 9) 
 
O bstei n K L  ( h ost a n d prese nter); Pa nelists: Be n nett A, C o yle WJ, J o u J, Sissel ma n A M.  
A S G E E n d o Ha n g o ut f or GI Fell o ws: Ma ki n g t he m ost of y o ur GI fell o ws hi p.  Se pte m ber 2, 
2 0 2 1. 
 

3 1  
 
O bstei n K L  ( h ost a n d prese nter); Pa nelists: P uri R, P hili p M.  A S G E T he Great Gastr o 
De bate: Piece meal E n d osc o pic M uc osal Resecti o n ( E M R) vs. E n d osc o pic S u b m uc osal 
Dissecti o n ( E S D).  N o ve m ber 2 0, 2 0 2 1. 
 
O bstei n K L  ( m o derat or).  A S G E D D W Fell o w De vel o pe d Best Case Re p orts f or A d va nce d 
L u mi nal GI.  Ma y 2 1, 2 0 2 2. 
 
 
O bstei n K L  ( prese nter); Pa nelists: Sa n d ulea n u S, Sa xe na P, C o he n J, Raj u R S.  A S G E D D W 
Cli nical S y m p osia: C ol o n osc o p y Ti ps a n d Tric ks: A Vi de o- Base d Sessi o n.  Ma y 2 1, 2 0 2 2. 
 
O bstei n K L  ( prese nter); A G A D D W Pr o m oti n g Di versit y i n GI: Pre pari n g f or t he B oar ds: 
Resi de nc y t hr o u g h Fell o ws hi p.  Ma y 2 2, 2 0 2 2. 
 
 
  
 

5 4  
 
 
 
 
 
 
 
 
 
 
A p pe n di x D : N A S A-T L X Q uesti o n n aire  
 
 
 
 

5 5  
 
N A S A -T L X Q uesti o n n aire  
E n d o T heia N u Vie w De vi ce 
 
Me nt al De m a n d  
H o w m uc h me ntal a n d p erce pt u al acti vit y was re q uire d (t hi n ki n g, deci di n g, pla n ni n g, 
calc ulati n g, searc hi n g) w he n usi n g t he N u Vie w d e vice a n d t he f or war d - vie wi n g e n d osc o pe? Was 
t he tas k eas y or d e ma n di n g, si m ple or c o m ple x, e xacti n g or f or gi vi n g? 
□ 
□ 
□ 
□ 
□ 
Ver y L o w  
L o w  
M o derate  
Hi g h  
Ver y Hi g h  
 
P h ysic al De m a n d 
H o w m uc h p h ysical acti vit y was re q uire d (i.e. p us hi n g, p ulli n g, t ur ni n g, c o ntr olli n g, acti vati n g) 
w he n usi n g t he N u Vie w de vice a n d t h e f or w ar d- vie wi n g e n d osc o pe? Was t he tas k p h ysicall y 
eas y or de m a n di n g, sl o w or bris k, restf ul or la b ori o us? 
□ 
□ 
□ 
□ 
□ 
Ver y L o w  
L o w  
M o derate  
Hi g h  
Ver y Hi g h  
 
Te m p or al De m a n d  
H o w m uc h ti me press ur e di d y o u feel w hile usi n g t he N u Vie w? Was t he p ace sl o w a n d leis urel y 
or ra pi d a n d fra ntic? 
□ 
□ 
□ 
□ 
□ 
Ver y L o w  
L o w  
M o derate  
Hi g h  
Ver y Hi g h  
 
Fr ustr ati o n Le vel  
H o w disc o ura g e d, stresse d, irritate d, a n d a n n o y e d vers us gratifie d, c o nte nt, a n d rela x e d di d y o u 
feel w hile usi n g t he N u Vie w de vice? 
□ 
□ 
□ 
□ 
□ 
Ver y L o w  
L o w  
M o derate  
Hi g h  
Ver y Hi g h  
 
 
 
 
 
O ver all Perf o r m a nce  
H o w s uccessf ul d o y o u t hi n k y o u were i n acc o m plis hi n g t he g oals of t he tas k w he n usi n g t he 
N u Vie w de vice? H o w satisfie d were y o u wit h y o ur perf or ma nce i n acc o m plis hi n g t hese g oals? 
□ 
□ 
□ 
□ 
□ 
Ver y P o or  
P o or  
M o derate  
G o o d  
Ver y G o o d  
 
Eff ort  
H o w har d di d y o u ha v e t o w or k ( me ntall y a n d p h ysicall y) t o acc o m plis h y o ur le vel of 
perf or ma n ce w h e n usi n g t he N u Vie w de vi ce?  
□ 
□ 
□ 
□ 
□ 
Ver y L o w  
L o w  
M o derate  
Hi g h  
Ver y Hi g h  
 
 
 
 
 
Vis u aliz ati o n Q u alit y  

5 6  
 
H o w w o ul d y o u rate t h e q ualit y of t he pa pilla vis ualizati o n w he n usi n g t he N u Vie w de vice? 
Were y o u a ble t o clearl y a n d c o m pre h e nsi vel y vis ualize t he pa pilla? Was t he vis ualizati o n 
q ualit y ne gati vel y i m pacte d b y de bris or o ccl usi o n? 
□ 
□ 
□ 
□ 
□ 
Ver y P o or  
P o or  
M o derate  
G o o d  
Ver y G o o d  
 
Ill u mi n ati o n Q u alit y 
H o w w o ul d y o u rate t h e q ualit y of t he ill u mi nati o n w he n usi n g t he N u Vie w de vice? Di d y o u 
ha ve a d e q uate li g hti n g t o carr y o ut y o ur cli nical o bjecti ve? 
□ 
□ 
□ 
□ 
□ 
Ver y P o or  
P o or  
M o derate  
G o o d  
Ver y G o o d  
 
 
 
A d a pte d fr o m: 
Hart, S. a n d Sta vela n d, L., ‘ De vel o p me nt of N A S A- T L X ( T as k L oa d I n d e x): Res ults of 
E m pirical a n d T he oretical Researc h.’ H u m a n Me nt al W orkl o a d, 1 9 8 8. p p. 1 3 9- 1 8 3. 
 
 

5 7  
A p pe n di x E : Inf or me d C o nse nt 

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
PI:  
0 4/ 2 5/ 2 0 2 2
0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
1  
T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
N a m e of p artici p a nt: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ A g e: _ _ _ _ _ _ _ _ _ _ _  
T h e f o ll o wi n g is gi v e n t o y o u t o t ell y o u a b o ut t his r es e arc h st u d y.  Pl e as e r e a d t his f or m wit h c ar e a n d 
as k a n y q u esti o ns y o u m a y h a v e a b o ut t his st u d y.  Y o ur q u esti o ns will b e a ns w er e d.  Als o, y o u will b e 
gi v e n a c o p y of t his c o ns e nt f or m.   
K e y i nf or m ati o n a b o ut t his st u d y:  
Y o u ar e b ei n g ask e d t o t a k e p art i n t his r es e arc h st u dy b ec a us e y o u ar e u n d er g oi n g scr e e ni n g r el at e d t o 
F a mili al A d e n o m at o us P ol y p osis ( F A P ) a n d y o ur m e dic al t e a m h as r ec o m m e n d e d y o u as a n exc ell e nt 
c a n di d at e f or e n d osc o pic vis u aliz ati o n of t h e p a pill a (t h e l oc ati o n w h er e y o ur bil e d uct e nt ers i nt o y o ur 
s m all i nt esti n e t h at is s usc e pti bl e t o p oly ps a n d c a nc er). T h e p ur p os e of t his st u dy is f or us t o e v al u at e  a 
n e w d evic e  t h at att ac h e s t o t h e e n d osc o p e t o all o w y o ur p hysici a n t o vis u aliz e y o ur  p a pill a  usi n g a si n gl e 
f or w ar d f aci n g g astr osc o p e i nst e a d of h avi n g t o us e t w o diff er e nt e n d osc o p es. T his r es e arc h h as t h e 
p ot e nti al t o r e d uc e pr oc e d ur e ti m e f or f ut ur e p ati e nts , r e d uc e t h e c h a nc e of i nf ecti o n, a n d t o off er a 
l o w er c ost o pti o n f or F A P scr e e ni n g.   
T his  st u dy is a l o w-risk st u dy t h at i nv ol v es all of t h e us u all y p erf or m e d st e ps i n t h e st a n d ar d of c ar e f or 
p ati e nts u n d er g oi n g a r o uti n e g astr osc o pic ex a mi n ati o n of t h e m uc os al li ni n g  f or F A P. T h e st u dy 
i ncl u d es a si n gl e i nv esti g ati o n al st e p i n w hic h t h e p hysici a n will att e m pt t o vis u aliz e y o ur  p a pill a by usi n g 
t h e i nv esti g ati o n al N u Vi e w e n d c a p . T his st e p will i ncl u d e att ac hi n g t h e N u Vi e w t o t h e e n d osc o p e a n d 
t h e n i ns erti n g t h e e n d osco p e i n t h e st a n d ar d cli nic al m et h o d t o c o nfir m vis u aliz ati o n of y o ur  p a pill a. 
F oll o wi n g t his st e p, t h e i nv esti g ati o n al d evic e will b e r e m o v e d fr o m t h e g astr osc o p e a n d r e m ai n d er  of 
y o ur e n d osc o py  will b e p erf or m e d as us u al p er t h e st a n d ar d of c ar e.  
T h er e will b e n o a d diti o n al visits b e y o n d t h e us u al st a n d ar d of c ar e r e q uir e d f or t his r es e arc h a n d t h e 
o v er all a m o u nt of ti m e r e q uir e d f or t h e i nv esti g ati o n al st e p is n e gli gi bl e i n t h e c o urs e of tr e at m e nt. 
Si mil arl y, n o a d diti o n al r estricti o ns or li mit ati o ns o n  d ail y activiti es d u e t o t h e i nv esti g ati o n al st e p ar e 
ex p ect e d.    
K e y I nf or m ati o n:  
T h e first s ecti o n of t his d oc u m e nt c o nt ai ns s o m e k e y p oi nts t h at t h e r es e arc h t e a m t h o u g ht y o u 
w o ul d fi n d i m p ort a nt. T h e st u dy is d escri b e d i n m or e d et ail aft er t his s ecti o n. If y o u d o n ot 
u n d erst a n d s o m et hi n g, pl e as e as k s o m e o n e.  
 

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h 
 
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
PI:  
0 4/ 2 5/ 2 0 2 2
0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
  
 
 
 
 
2  
T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
 
Y o u d o n ot h a v e t o b e i n t his r es e arc h st u dy. Y o u m a y c h o os e n ot t o b e i n t his st u dy a n d g et ot h er 
tr e at m e nts wit h o ut c h a n gi n g y o ur h e alt hc ar e, s ervic es, or ot h er ri g hts.   Y o u c a n st o p b ei n g i n t his st u dy 
at a ny ti m e.  If w e l e ar n s o m et hi n g n e w t h at m a y aff ect t h e ris ks or b e n efits of t his st u dy, y o u will b e 
t ol d s o t h at y o u c a n d eci d e w h et h er or n ot y o u still w a nt t o b e i n t his st u dy.   Y o ur m e dic al r ec or d will 
c o nt ai n a n ot e s ayi n g y o u are i n a r es e arc h st u dy a n d m a y c o nt ai n s o m e r es e arc h i nf or m ati o n a b o ut 
y o u.  A ny o n e y o u a ut h oriz e t o r ec ei v e y o ur m e dic al r ec or d will als o g et t his i nf or m ati o n . 
 
 
 
Si d e eff ects a n d ris ks t h at y o u c a n e x p ect if y o u t a k e p art i n t his st u d y:  
T h er e ar e risks ass oci at e d wit h a ny e n d osc o pic pr oc e d ur e  a n d wit h A n est h esi a ( M o nit or e d A n est h esi a 
C ar e:  M A C). T h es e ris ks ar e r ar e (l ess t h a n 1 %) a n d i ncl u d e b ut ar e n ot li mit e d t o bl e e di n g, i nf ecti o n, 
tiss u e tr a u m a, str o k e, a n d/ or t h e n e e d f or a d diti o n al s ur g er y. T h es e sur gic al ris ks ass oci at e d wit h 
e n d osc o py a n d a n est h esi a  ar e r ar e a n d n o gr e at er f or p atie nts r ec eivi n g t h e i nv esti g ati o n al  pr oc e d ur e 
t h a n f or t h e st a n d ar d of c ar e pr oc e d ur es . 
 
A d diti o n al ris ks ass oci at e d wit h t his st u dy ar e as f oll o ws:  
 
D et ac h m e nts  e v e nts : as wit h a ny dist al e n d osc o p e att ac h m e nt, t h e d evic e m ay b ec o m e d et ac h e d fr o m 
t h e e n d osc o p e. T his ev e nt is ex p ect e d t o b e r ar e (l ess t h a n 1 %) a n d t h e o nly h ar m ex p ect e d is a sli g ht 
d el ay ( 4 5 -1 2 0 s ec o n ds) t o i n t h e pr oc e d ur e ti m e as t h e d evic e is r etri ev e d.  
 
St erilit y: as wit h a ny e n d osc o pic pr oc e d ur e, st erilit y is a n i m p ort a nt c o nsi d er ati o n i n or d er t o pr e v e nt 
i nf ecti o n. T h e i nv esti g ati o n al d e vic e h as b e e n st eriliz e d pri or t o us e.  
 
Bi oc o m p ati bilit y: as wit h a ny m e dic al d evic e bi oc o m p ati bilit y is i m p ort a nt t o pr ev e nt all er gic r e acti o ns. 
T h e i nv esti g ati o n al d evic e is m a d e fr o m 1 0 0 % bi oc o m p ati bl e m at eri als t h at h av e b e e n t est e d t o I S O 
1 0 9 9 3 -1 st a n d ar ds.  
 
Tiss u e tr a u m a a n d d e vic e br e a k a g es/f ail ur es: as wit h a ny e n d osc o pic m e dic al d evic e, tiss u e tr a u m a is a 
p ot e nti al s af et y c o nsi d er ati o n. T h e i nv esti g ati o n al d e vic e h as b e e n d esi g n e d t o b e atr a u m atic a n d h as 
u n d er g o n e v erific ati o n t esti n g t o v erify its s af et y .  
 
D et ail e d I nf or m ati o n:  
T h e r est of t his d oc u m e nt i ncl u d es d et ail e d i nf or m ati o n a b o ut t his st u dy (i n a d diti o n t o t h e 
i nf or m ati o n list e d a b o v e). 

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
PI:  
0 4/ 2 5/ 2 0 2 2
0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
3  
T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
D evic e f ail ur es a n d br e a k a g es: as wit h a ny m e dic al d evic e t h er e is a p ot e nti al f or d e vic e br e a k a g es a n d 
f ail ur es d uri n g t h e pr oc e d ur e. Wit h r e g ar d t o t h e i nv esti g ati o n al d e vic e, e v e n if  t h e d e vic e d o es br e a k or 
f ails, t h e o nl y ex p ect e d h ar m w o ul d b e a sli g ht i ncr e as e ( 4 5-1 2 0 s ec o n ds)  i n pr oc e d ur e ti m e as t h e d evic e 
is r etri ev e d a n d disc ar d e d.    
Ris k s t h at ar e n ot k n o w n: 
B ec a us e t his tr e at m e nt is i nv esti g ati o n al, m e a ni n g n o n -F D A a p pr ov e d, t h er e m ay b e risks t h at w e d o n ot 
k n o w a b o ut at t his ti m e.   
Ot h er  Ris ks:  
N/ A  
G o o d e ff ects t h at mi g ht r es ult fr o m t his st u d y:  
T h e b e n efits t o sci e nc e a n d h u m a n ki n d t h at mi g ht  r es ult fr o m t his st u dy: 
S u bs e q u e nt p hysici a ns m a y b e n efit fr o m t h e pr o p os e d r es e arc h by h avi n g acc ess  i n t h e f ut ur e t o t h e b est 
p ot e nti al p ati e nt c ar e o pti o ns , r e d uci n g i nf ecti o ns, a n d by h avi n g a m or e c ost -eff ecti v e tr e at m e nt o pti o n  
av ail a bl e .  
S u bs e q u e nt p ati e nts m ay b e n efit fr o m t h e pr o p os e d r es e arc h by h avi n g a d ecr e as e d ov er all pr oc e d ur e 
ti m e d uri n g F A P ex a mi n atio n a n d by a r e d ucti o n of p ot e nti al f or tiss u e d a m a g e by d ecr e asi n g t h e n u m b er 
of e n d osc o p e i ns erti o ns d uri n g t h e pr oc e d ur e (t h e i nv esti g ati o n al d e vic e h as t h e p ot e nti al t o eli mi n at e 
o n e of t h e t w o e n d osc o p es fr o m b ei n g us e d i n t h e st a n d ar d of c ar e f or p ati e nts wit h F A P). F urt h er, wi d e 
sc al e  a d o pti o n  of  t h e  i nv esti g ati o n al  d evic e  h as  t h e  p ot e nti al  t o  r e d uc e  c osts  ass oci at e d  wit h  t h e  
pr oc e d ur e  
Pr oc e d ur es t o b e f oll o w e d:  
T h e b el o w t a bl e o utli n es t h e pl a n n e d st u dy pr oc e d ur es. T h e pr oc e d ur e will i ncl u d e 1) I nf or m e d c o ns e nt, 
2) r evi e w of t h e i ncl usi o n/ excl usi o n crit eri a, 3) r evi e w of m e dic al hist ory, 4) a r o uti n e pr e g n a nc y t est f or
w o m e n of c hil d b e ari n g a g e, 5) g astr osc o p e ass ess m e nt of tiss u e, 6) e n d osc o pic  v ali d ati o n of t h e tar g et
wit h t h e i nv esti g ati o n al d evic e, 7) e n d osc o pic c o nfir m ati o n of t h e t ar g et usi n g a st a n d ar d
d u o d e n osc o p e, 8)  r evi e w of a dv ers e ev e nts, a n d 9) e n d osc o pic p ost -o p N A S A/ q u esti o n n air e c o m pl et e d
by t h e p hysici a n.

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
PI:  
0 4/ 2 5/ 2 0 2 2
0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
4  
T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
St u d y Pr o c e d ur e s  
Scr e e ni n g  
E n d osc o pic 
E x a mi n ati o n 
F oll o w  u p 
O bt ai n  I nf or m e d C o ns e nt  
X  
R evi e w  I ncl usi o n/ Excl usi o n Crit eri a  
X  
R evi e w  M e dic al  Hist or y  
X  
R o uti n e Pr e g n a nc y T esti n g ( uri n e or  
bl o o d)  
X  a 
G astr osc o p e ass ess m e nt of tiss u e  
X  
E n d osc o pic  V ali d ati o n of t ar g et wit h 
t h e N u Vi e w 
X b  
E n d osc o pic  c o nfir m ati o n  of  t ar g et  
usi n g a st a n d ar d D u o d e n osc o p e  
X 
R evi e w A dv ers e  E v e nts  
X  
X  
E n d osc o pic P ost -O p 
N A S A/ Q u esti o n n air e  
X b  
( a) P erf or m e d  pr e -o p er ativ el y  f or w o m e n  of c hil d b e ari n g  p ot e nti al
( b) T h e I nv esti g ati o n al St e p i n t his st u dy pr oc e d ur e. All ot h er st e ps wit hi n t h e pr ot oc ol will b e p erf or m e d p er t h e st a n d ar d of c ar e
P a y m e nts f or y o ur ti m e s p e nt t a ki n g p art i n t his st u d y or e x p e ns es:  
Y o u will n ot b e c o m p e ns at e d f or t a ki n g p art of t his st u dy.  
C os ts to y o u if y o u t a k e p art i n t his st u d y:  
If y o u a gr e e t o t a k e p art i n t his r es e arc h st u dy, y o u a n d/ or y o ur i ns ur a nc e will n ot h a v e t o p a y f or t h e 
t ests a n d tr e at m e nts t h at ar e b ei n g d o n e o nly f or r es e arc h.  H o w ev er, y o u ar e still r es p o nsi bl e f or 
p a yi n g f or t h e us u al c ar e y o u w o ul d n or m ally r ec ei v e f or t h e tr e at m e nt of y o ur ill n ess. T his i ncl u d es 
tr e at m e nts a n d t ests y o u w o ul d n e e d e v e n if y o u w er e n ot i n t his st u dy. T h es e c osts will b e bill e d t o y o u 
a n d/ or y o ur i ns ur a nc e.  
Y o u h av e t h e ri g ht t o as k w h at it m a y c ost y o u t o t a k e p art i n t his st u dy.  If y o u w o ul d li k e assist a nc e, 
fi n a nci al c o u ns eli n g is a v ail a bl e t hr o u g h t h e V a n d er bilt Fi n a nci al Assist a nc e Pr o gr a m.  T h e st u dy st aff 
c a n h el p y o u c o nt act t his pr o gr a m. Y o u h a v e t h e ri g ht t o c o nt act y o ur i ns ur a nc e c o m p a ny t o disc uss t h e 
c osts of y o ur r o utin e c ar e ( n o n -r es e arc h) f urt h er b ef or e c h o osi n g t o b e i n t h e st u dy. Y o u m ay c h o os e 
n ot t o b e i n t his st u dy if y o ur i ns ur a nc e d o es n ot p ay f or y o ur r o uti n e c ar e ( n o n -r es e arc h) c osts a n d y o ur 
d oct or will disc uss ot h er tr e at m e nt pl a ns wit h y o u.  
P a y m e nt i n c as e y o u ar e i nj ur e d b ec a us e of t his r es e arc h st u d y: 

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h 
 
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
PI:  
0 4/ 2 5/ 2 0 2 2
0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
  
 
 
 
 
5  
T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
 
If it is d et er mi n e d by V a n d er bilt a n d t h e I nv esti g at or ( wit h i n p ut fr o m E n d o T h ei a, Inc .) t h at a n i nj ur y 
occ urr e d, t h e n y o u a n d/ or y o ur i ns ur a nc e m a y b e bill e d f or t h e c ost of m e dic al c ar e pr ovi d e d at 
V a n d er bilt t o tr e at t h e i nj ur y.  Y o u will b e r es p o nsi bl e f or a ny c o p a y m e nts or d e d ucti bl es ass oci at e d 
wit h t h e tr e at m e nt of t h at i nj ur y.  
 
T h er e ar e n o pl a ns f or V a n d er bilt  or E n d o T h ei a, I nc.  t o p a y f or t h e c osts of a ny a d diti o n al c ar e. T h er e ar e 
n o pl a ns f or V a n d er bilt or E n d o T h ei a, i nc. t o gi v e y o u m o n e y f or t h e i nj ur y.  
 
W h o t o c all f or a n y q u esti o ns or i n c as e y o u ar e i nj ur e d:  
If y o u s h o ul d h av e a ny q u esti o ns a b o ut t his r es e arc h st u dy or if y o u f e el y o u h a v e b e e n h urt by b ei n g a 
p art of t his st u dy, pl e as e f e el fr e e t o c o nt act C as e y K oz a, R N at ( 6 1 5) 8 7 5-6 6 4 2 or Dr. K eit h O bst ei n  at 
(6 1 5) 8 7 5- 5 8 5 6 . If y o u c a n n ot r e ac h t h e r es e arc h st aff, pl e as e p a g e t h e st u dy d oct or at 6 1 5 -8 3 1 -6 2 9 2.  
 
F or a d diti o n al i nf or m ati o n a b o ut gi vi n g c o ns e nt or y o ur ri g hts as a p ers o n i n t his st u dy, t o disc uss 
pr o bl e ms, c o nc er ns, a n d q u esti o ns, or t o off er i n p ut, pl e as e f e el fr e e t o c all t h e V U M C I nstit uti o n al 
R e vi e w B o ar d Offic e at ( 6 1 5) 3 2 2 -2 9 1 8 or t oll fr e e at ( 8 6 6) 2 2 4 -8 2 7 3.  
 
R e as o ns w h y t h e st u d y d oct or m a y t a k e y o u o ut of t his st u d y:  
P artici p a nts will b e r e m o v e d fr o m t his st u dy if t h ey ask t o b e r e m ov e d. S u bj ects m a y d ecli n e 
p artici p ati o n at a ny ti m e by i nf or mi n g K eit h O bst ei n ( 6 1 5 -8 7 5 -5 8 5 6).  
 
W h at will h a p p e n if y o u d eci d e t o st o p b ei n g i n t his st u d y ?  
If y o u d eci d e t o st o p b ei n g p art of t h e st u dy, y o u s h o ul d t ell y o ur st u dy d oct or.  D eci di n g t o n ot b e p art 
of t h e st u dy will n ot c h a n g e y o ur r e g ul ar m e dic al c ar e i n a ny w a y.  
 
 
C o nfi d e nti alit y:   
P artici p a nts will r ec eiv e a 3 -di git i d e ntific ati o n n u m b er fr o m 0 0 1 -0 0 3 i n t h e or d er of t h eir e nr oll m e nt. 
P ati e nt i d e ntific ati o n n u m b ers will b e li n k e d t o t h eir n a m e o n a p ass w or d s ec ur e d V a n d er bilt U ni v ersity 
C o m p ut er o nl y acc essi bl e by a p pr ov e d r es e arc h st u dy st aff. T h e fi el d n ot es a n d i nt er vi e w n ot es t ak e n by 
a ny o bs erv ers wil l n ot c o nt ai n a ny i d e ntifi a bl e i nf or m ati o n. A ny e n d osc o pic vi d e o/ a u di o r ec or di n g will 
n ot c o nt ai n a ny i d e ntifi a bl e i nf or m ati o n. At t h e c o ncl usi o n of t h e r es e arc h st u dy, t h e PI will m ai nt ai n all 
t h e i nf or m ati o n o n a s ec ur e, e ncry pt e d, V a n d er bilt U ni v ersity c o m p ut er. 
 
V a n d er bilt m ay s h ar e y o ur i nf or m ati o n, wit h o ut i d e ntifi ers, t o ot h ers or us e it f or ot h er r es e arc h 
pr oj ects n ot list e d i n t his f or m. V a n d er bilt, Dr. O bst ei n (t h e PI), a n d his st aff will c o m ply wit h a ny a n d all 

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
PI:  
0 4/ 2 5/ 2 0 2 2
0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
6  
T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
l a ws r e g ar di n g t h e pri v ac y of s uc h i nf or m ati o n. T h er e ar e n o pl a ns t o p a y y o u f or t h e us e or tr a nsf er of 
t his d e-i d e ntifi e d i nf or m ati o n. 
Pri v a c y: 
Inf or m ati o n t h e pr oc e d ur e m a y b e m a d e av ail a bl e t o ot h ers t o us e f or r es e arc h.  T o pr ot ect y o ur priv ac y, 
w e will n ot r el e as e y o ur n a m e.   
St u d y R es ults : 
R es ults will b e s h ar e d ( u p o n r e q u est) wit h p artici p a nts f or t h eir r es p ecti v e pr oc e d ur e. 
A ut h or iz ati o n t o Us e/ Discl os e Pr ot ect e d H e alt h I nf or m ati o n  
W h at i nf or m ati o n is b ei n g c oll ect e d, us e d, or s h ar e d ?  
T o d o t his r es e arc h, w e will n e e d t o c oll ect, us e, a n d s h ar e y o ur pri v at e h e alt h i nf or m ati o n.   B y si g ni n g 
t his d oc u m e nt, y o u a gr e e t h at y o ur h e alt h c ar e pr ovi d ers (i ncl u di n g b ot h V a n d er bilt U ni v ersit y M e dic al 
C e nt er  a n d ot h ers) m ay r el e as e y o ur pri v at e h e alt h i nf or m ati o n t o us, a n d t h at w e m a y us e a ny a n d all 
of y o ur i nf or m ati o n t h at t h e st u dy t e a m b eli e v es it n e e ds t o c o n d uct t h e st u dy.   Y o ur priv at e 
i nf or m ati o n m ay i ncl u d e t hi n gs l e ar n e d fr o m t h e pr oc e d ur es d escri b e d i n t his c o ns e nt f or m, as w ell as 
i nf or m ati o n fr o m y o ur m e dic al r ec or d ( w hic h m ay i ncl u d e i nf or m ati o n s uc h as HI V st at us, dr u g, alc o h ol 
or S T D tr e at m e nt, g e n etic t est r es ults, or m e nt al h e alt h tr e at m e nt).     
W h o wil l s e e, us e or s h ar e t h e i nf or m ati o n ? 
T h e p e o pl e w h o m ay r e q u est, r ec ei v e or us e y o ur pri v at e h e alt h i nf or m ati o n i ncl u d e t h e r es e arc h ers a n d 
t h eir st aff.  A d diti o n ally, w e m a y s h ar e y o ur i nf or m ati o n wi t h ot h er p e o pl e at V a n d er bilt, f or ex am pl e if 
n e e d e d f or y o ur cli nic al c ar e or st u dy ov ersi g ht.   B y si g ni n g t his f or m, y o u giv e p er missi o n t o t h e 
r es e arc h t e a m t o s h ar e y o ur i nf or m ati o n wit h ot h ers o utsi d e of V a n d er bilt U niv ersit y M e dic al 
C e nt er.   T his m a y i ncl u d e t h e s p o ns or of t h e st u dy a n d its a g e nts or c o ntr act ors, o utsi d e pr ovi d ers, st u dy 
s af et y m o nit ors, g ov er n m e nt a g e nci es, ot h er sit es i n t h e st u dy, d at a m a n a g ers a n d ot h er a g e nts a n d 
c o ntr act ors us e d by t h e st u dy t e a m.    W e try t o m a k e s ur e t h at e v er y o n e w h o s e es y o ur i nf or m ati o n 
k e e ps it c o nfi d e nti al, b ut w e c a n n ot g u ar a nt e e t h at y o ur i nf or m ati o n will n ot b e s h ar e d wit h ot h ers.  If 
y o ur i nf or m ati o n is discl os e d by y o ur h e alt h c ar e pr ovi d ers or t h e r es e arc h t e a m t o ot h ers, f e d er al a n d 
st at e c o nfi d e nti alit y l a ws m a y n o l o n g er pr ot ect it.  
D o y o u h a v e t o si g n t his A ut h oriz ati o n ?  
Y o u d o n ot h a v e t o si g n t his A ut h oriz ati o n, b ut if y o u d o n ot, y o u m ay n ot j oi n t h e st u dy.  
H o w l o n g will y o ur i nf or m ati o n b e us e d or s h ar e d ?  

V U M C I nstit uti o nal Revi e w B oar d 
I nf or m e d C o ns e nt D oc u m e nt f or R es e arc h
St u dy Titl e:
St u dy Titl e: 
Vis u aliz ati o n of t h e 
Vis u aliz ati o n of t h e p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P
p a pill a t hr o u g h us e of t h e N u Vi e w d evic e i n p ati e nts wit h F A P  
V ersi o n D at e:
V ersi o n D at e:  
PI:
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0 4/ 2 5/ 2 0 2 2  
Dr. K eit h L. O bst ei n
Dr. K eit h L. O bst ei n  
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T his b ox is f or  
I R B U S E O NL Y 
D o n ot e dit or d el et e  
Y o ur A ut h oriz ati o n f or t h e c oll ecti o n, us e, a n d s h ari n g of y o ur i nf or m ati o n d o es n ot ex pir e.  A d diti o n all y, 
y o u a gr e e t h at y o ur i nf or m ati o n m a y b e us e d f or si mil ar or r el at e d f ut ur e r es e arc h st u di es.  
W h at if  y o u c h a n g e y o ur mi n d ? 
Y o u m ay c h a n g e y o ur mi n d a n d c a nc el t his A ut h oriz ati o n at a ny ti m e.   If y o u c a nc el, y o u m ust c o nt act t h e 
Pri nci p al I nv esti g at or i n writi n g t o l et t h e m k n o w by usi n g t h e c o nt act i nf or m ati o n pr o vi d e d i n t his c o ns e nt 
f or m.  Y o ur c a nc ell ati o n will n ot aff ect i nf or m ati o n alr e a dy c oll ect e d i n t h e st u dy, or i nf or m ati o n t h at h as 
alr e a dy b e e n s h ar e d wit h ot h ers b ef or e y o u c a nc ell e d y o ur a ut h oriz ati o n.  
If y ou d eci d e n ot t o t a k e p art i n t his r es e arc h st u d y, it will n ot aff ect y o ur tr e at m e nt, p a y m e nt or 
e nr oll m e nt i n a n y h e alt h pl a ns or aff ect y o ur a bilit y t o g et b e n efits. Y o u will g et a c o p y of t his f or m 
aft er it is si g n e d.  
S T A T E M E N T B Y P E R S O N A G R E EI N G T O B E I N T HI S S T U D Y  
I h a v e r e a d t his c o ns e nt f or m a n d t h e r es e arc h st u d y h as b e e n e x pl ai n e d t o m e v er b all y.  All m y 
q u esti o ns h a v e b e e n a ns w er e d, a n d I fr e el y a n d v ol u nt aril y c h o os e t o t a k e p art i n t his st u d y.    
D at e  
Si g n at ur e of p ati e nt/ v ol u nt e er  
Ti m e  
C o ns e nt o bt ai n e d by:  
D at e  
Si g n at ur e  
Ti m e  
Pri nt e d N a m e a n d Titl e