A Prospective, Non-significant Risk, Feasibility Study to Evaluate Serial Applications of VibratoSleeve Therapy to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) Subjects 65 Years of Age and Older
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: Vibrato Medical, Inc.

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Vi br at o  M e dic al, I nc. : P h as e I  St u dy                                                                                                                   P a g e 3 of 5  
Pr ot oc ol  N o: 0 2 2 -0 1 . V ersi o n 1 . 0 
 
1.   P R O T O C OL SY N O P SI S  
 
Titl e:  
W AL T Z: a pr os p ecti v e, n o n -si g nific a nt ris k, f e asi bilit y st u d y t o ev al u at e s eri al 
9 0 -mi n ut e a p plic ati o ns of Vi br at o Sl e ev e t h er a p y t o ac ut el y i ncr e as e t h e 
p erf usi o n i n p eri p h er al art eri al dis e as e ( P A D) s u bj ects 6 5 y e ars of a g e a n d 
ol d er.  
 
D esi g n:  
Pr os p ecti v e, si n gl e ar m, o p e n -l a b el cli nic al tri al t o ev al u at e t h e f e asi bilit y of 
T U S i n t h e tr e at m e nt of e arl y st a g e ( R ut h erf or d Cl ass 1 -3) P A D.  T h e  r es ults of 
t his st u d y will b e us e d t o s u p p ort f ut ur e st u di es.  
 
D evic e N a m e  
a n d I nt e n d e d Us e:  
Vi br at o Sl e ev e is a n arr a y of si n gl e el e m e nt ultr as o u n d tr a ns d uc ers, dri v e n i n 
a p h as e d m a n n er, a n d h el d i n pl ac e ext er n all y b y a n a dj ust a bl e sl e ev e.  
 
I n t his st u d y, t h e Vi br at o Sl e ev e will b e a p pli e d i n cli nic a n d will b e  t est e d t o 
d e m o nstr at e evi d e nc e of a n i ncr e as e i n dist al li m b p erf usi o n i n a d ults wit h 
P A D.  
 
Visit Sc h e d ul e:  
Visits will occ ur at scr e e ni n g  (b as eli n e  d at a)  a n d  at  t hr e e i n-cli nic tr e at m e nt 
s essi o ns, e ac h s e p ar at e d b y at l e ast a 1- w e e k i nt er v al.  
 
St u d y O bj ecti v es:  
T h e o bj ecti v es of t his st u d y ar e:  
•  
T o d et er mi n e t h e f e asi bilit y of Vi br at o Sl e ev e t h er a p y t o ac ut el y 
i ncr e as e dist al  p erf usi o n  i n p eri p h er al art eri al dis e as e ( P A D) s u bj ects 
6 5 y e ars of a g e  a n d ov er .  
•  
C oll ect d at a o n t ol er a bl e ac o ustic d os e  of s eri al 9 0-mi n ut e T U S  
t h er a p y i n t h e tr e at m e nt of e arl y st a g e ( R ut h erf or d Cl ass 1 -3) P A D . 
•  
Ev al u at e s u bj ect f e e d b ac k o n w e ar a bilit y a n d t ol er a bilit y of s eri al 9 0-
mi n ut e T U S t h er a p y.  
•  
Ev al u at e t h e n at ur e, i nci d e nc e, ti mi n g a n d r es ol uti o n of all a dv ers e 
ev e nts i n s u bj ects tr e at e d wit h Vi br at o Sl e ev e as c o m p ar e d wit h 
hist oric al d at a o n c urr e nt st a n d ar d of c ar e tr e at m e nts f or P A D.  
 
N u m b er of S u bj ects  
a n d D efi n e d P oi nt of 
E nr oll m e nt  
A t ot al of u p t o 1 2  s u bj ects will b e r e q uir e d  t o r ec ei v e Vi br at o Sl e ev e t h er a p y.  
 
T h e p oi nt of e nr oll m e nt is d efi n e d as t h e ti m e t h e s u bj ect si g ns t h e I nf or m e d 
C o ns e nt F or m  (I C F) t o u n d er g o scr e e ni n g pr oc e d ur es t o asc ert ai n eli gi bilit y. It 
is a ntici p at e d t h at u p t o 5 0 % of s u bj ects e nr oll e d i n t h e st u d y will m e et t h e 
i ncl usi o n/ excl usi o n crit eri a. Gi v e n t h e scr e e n s ucc ess r at e, it is a ntici p at e d 
t h at a p pr oxi m at el y 2 4 s u bj ects c o ul d b e e nr oll e d  i n t h e st u d y t o h a v e 1 2  
ev al u a bl e s u bj ects q u alifi e d f or t h e tr e at m e nt a n d ev al u ati o n. 
 
 
 

Vi br at o  M e dic al, I nc. : P h as e I  St u dy                                                                                                                   P a g e 4 of 5  
Pr ot oc ol  N o: 0 2 2 -0 1 . V ersi o n 1 . 0 
 
I ncl usi o n Crit eri a 
1.  A g e ≥ 6 5  
2.  Di a g n osis of P A D.  
3.  Cl a u dic ati o n s y m pt o ms i n R ut h erf or d cl ass 1,  2, or 3 as d et er mi n e d b y t h e 
i n v esti g at or.  
 
Excl usi o n Crit eri a  
 
1.  Pri or st e nti n g i n p ost eri or ti bi al art er y.  
2.  R e -v asc ul ariz ati o n pr oc e d ur e wit hi n 3 0 d a ys pri or t o e nr oll m e nt i n t h e 
st u d y.  
3.  Ulc ers, c ell ulitis, or s ki n br e a k d o w n i n tr e at m e nt ar e as ( p ost eri or c alf).  
4.  Hist or y or di a g n osis of s ev er e c hr o nic v e n o us i ns uffici e nc y.  
5.  Ac ut e li m b isc h e mi a wit hi n 3 0 d a ys pri or t o tr e at m e nt.  
6.  Hist or y or di a g n osis of d e e p v e n o us t hr o m b osis b el o w t h e k n e e i n 
tr e at m e nt l e g. 
7.  A n y c o n diti o ns t h at, i n t h e o pi ni o n of t h e i nv esti g at or, m a y r e n d er t h e 
s u bj ect u n a bl e t o c o m pl et e t h e st u d y or l e a d t o diffic ulti es f or s u bj ect 
c o m pli a nc e wit h st u d y r e q uir e m e nts, or c o ul d c o nf o u n d st u d y d at a.  
8.  S u bj ect ’s e nr oll m e nt i n a n ot h er i n v esti g ati o n al st u d y t h at h as n ot 
c o m pl et e d t h e r e q uir e d pri m ar y e n d p oi nt f oll o w -u p p eri o d.  
 
S af et y E n d p oi nt  
All d evic e a n d pr oc e d ur e r el at e d a dv ers e cli nic al ev e nts ex p eri e nc e d b y  
s u bj ects will b e c oll ect e d. S u m m ari es of a dv ers e ev e nts  will b e pr ovi d e d o n a 
p er s u bj ect a n d a p er d evic e  b asis. S ev erit y  a n d m et h o d of r es ol uti o n will als o 
b e s u m m ariz e d. T h e n u m b er a n d pri m ar y r e as o ns f or  m e dic al or s ur gic al 
i nt er v e nti o ns t o tr e at d evic e r el at e d a d v ers e ev e nts will b e s u m m ariz e d.  
T his st u d y is n ot p o w er e d t o d efi niti v el y ev al u at e t h e s af et y of t h e 
i n v esti g ati o n al d evic e as c o m p ar e d t o t h e hist oric al d at a of c o m p ar a bl e 
tr e at m e nts f or P A D. 
 
Effic acy E n d p oi nts  
T h e f oll o wi n g p ar a m et ers will b e ev al u at e d t o ass ess p erf or m a nc e of t h e 
Vi br at o Sl e ev e T U S:   
•  
T h e m e a n i m pr ov e m e nt i n Fl o w M et p erf usi o n r at e  as m e as ur e d b y 
t h e n o ni nv asi v e F D A -a p pr ov e d i m a gi n g s yst e m Fl o w M et.  E ac h 
s u bj ect’s pr e-tr e at m e nt b as eli n e p erf usi o n r at e will b e c alc ul at e d 
fr o m at l e ast 5 mi n ut es ( m e a n of 3 0 0 Fl o w M et m e as ur e m e nts w hic h 
ar e t a k e n o nc e a s ec o n d) as B as eli n e p eri o d. T h e m e a n of t h e 9 0 
mi n ut es of t h e tr e at m e nt p eri o d will t h e n b e n or m aliz e d  t o t h e pr e-
tr e at m e nt b as eli n e t o d et er mi n e t h e p erc e nt a g e c h a n g e i n p erf usi o n 
r at e.  
•  
Tiss u e ox y g e n s at ur ati o n a n d h e m o gl o bi n c o nt e nt as m e as ur e d b y 
t h e n o ni nv asi v e F D A -a p pr ov e d i m a gi n g s yst e m Cl arifi   ( St O2). . Cl arifi 
m e as ur e m e nts will b e t a k e n b ef or e ( b as eli n e), d uri n g a n d aft er 
tr e at m e nt. 

Vi br at o  M e dic al, I nc. : P h as e I  St u dy                                                                                                                   P a g e 5 of 5  
Pr ot oc ol  N o: 0 2 2 -0 1 . V ersi o n 1 . 0 
 
•  
A n kl e a n d T o e Br ac hi al I n dic es ( A BI, T BI).  I m pr ov e m e nt i n A BI, T BI will 
b e si mil arl y c o m p ar e d f or all s u bj ects. A BI a n d T BI will b e t a k e n 
b ef or e a n d aft er e ac h tr e at m e nt  
•  
Q u alit y of Lif e wit h V asc u Q oL a n d W al ki n g I m p air m e nt 
Q u esti o n n air e s 
 
M e a n c h a n g es of  all  t h es e e n d p oi nts fr o m b as eli n e d uri n g t h e tr e at m e nt a n d 
t o p ost-tr e at m e nt will b e a n al yz e d.  
Tr e at m e nt  
I n t his pr ot oc ol, t h er a p y will b e d eli v er e d at VI S O C cli nic d uri n g 3 s e p ar at e 
visits wit h at l e ast 1 -w e e k i nt erv al b et w e e n e ac h visit. T U S t h er a p y will l ast 
f or 9 0 mi n ut es d uri n g e ac h tr e at m e nt visit .  
E ac h s u bj ect will r ec ei v e eit h er l o w, m e di u m or hi g h ac o ustic i nt e nsit y 
( v ar yi n g p e a k n e g ati v e pr ess ur e) of T U S at a tr e at m e nt visit a n d all s u bj ects 
will r ec ei v e all 3 l ev els of i nt e nsit y d uri n g t h e st u d y.  
 
R e g ul ar m o nit ori n g will b e c o n d uct e d t o e ns ur e s u bj ect c o m pli a nc e wit h 
t h er a p y d uri n g tr e at m e nt.  
 
S u bj ects  will b e disc h ar g e d fr o m t h e st u d y aft er Tr e at m e nt Visit 3 or u ntil a n y 
d evic e or pr oc e d ur e a dv ers e ev e nts ar e r es ol v e d or r e m ai n st a bl e.   
 
St atistic al 
Hy p ot h esis  
St atistic al h y p ot h es es will n ot b e a p pli e d i n t his pil ot st u d y.  T a bl es a n d 
d escri pti v e st atistics of t h e s u bj ect d e m o gr a p hic d at a, tr e at m e nt p ar a m et ers, 
a n d o utc o m e v ari a bl es will b e g e n er at e d at t h e c o m pl eti o n of t h e st u d y.  
I nf or m ati o n c oll ect e d d uri n g t h e st u d y m a y b e us e d t o s u p p ort a 5 1 0( k) 
a p plic ati o n as w ell as t o s el ect t h e e n d p oi nts a n d d et er mi n e s a m pl e siz es f or 
f ut ur e tri als.  
  
St u d y D ur ati o n  
T h e S p o ns or ex p ects t h e tri al t o l ast  six m o nt hs fr o m t h e ti m e t h e first 
s u bj ect e nr olls u ntil t h e ti m e of t h e l ast visit.