c urric ul u m
pr oc e d ur

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.  
3  
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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


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V ersi o n D at e: V ersi o n D at e:  
PI:  
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  
0 4/ 2 5/ 2 0 2 20 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  
| 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  R evi e w I ncl usi o n/ Excl usi o n Crit eri a  R evi e w M e dic al Hist or y  R o uti n e Pr e g n a nc y T esti n g ( uri n e or  bl o o d)                                                                                                                                                          | 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  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  ( 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 |                                     |               |
c urric ul u m
c os ts to 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:
4  
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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


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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:   | 0 4/ 2 5/ 2 0 2 20 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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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.  
```
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


```
c urric ul u m
c o nfi d e

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 er v 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 5  
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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


```  
| V ersi o n D at e: V ersi o n D at e:  PI:   | 0 4/ 2 5/ 2 0 2 20 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   |
|----------------------------------------------|-------------------------------------------------------------------------------------------|  
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  
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 pri v 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).  
```
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


```
c urric ul u m
w h o wil l

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 ?  
6  
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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


```  
| V ersi o n D at e: V ersi o n D at e:  PI:   | 0 4/ 2 5/ 2 0 2 20 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   |
|----------------------------------------------|-------------------------------------------------------------------------------------------|  
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  
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.  
```
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,


```  
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.
c urric ul u m
s t a t e

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  
D at e Si g n at ur e  
| Ti m e   |
|----------|  
| C o ns e nt o bt ai n e d by:   |
|---------------------------------|  
Ti m e Pri nt e d N a m e a n d Titl e  
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