Bariatric Embolization of Arteries for the Treatment of Obesity
Phase: NA
Conditions: Morbid Obesity
Sponsor: Johns Hopkins University

 
Study Title: Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) 
 
NCT02165124 
 
PI: Clifford R Weiss, M.D. 
 
Date: 12/17/2015 

 
ORIGINAL APPLICATION FOR  
INVESTIGATIONAL DEVICE EXEMPTION (IDE)  
 
 
Feasibility and Safety Study: 
Bariatric Embolization for Suppression of Ghrelin Level to Induce Weight Loss 
July 31, 2015.  UPDATED for JHU IRB 12/17/2015 
 
   
 
Study Sponsor:  
 
Aravind Arepally, M.D., FSIR 
Division of Interventional Radiology 
Piedmont Healthcare 
 
Principal Investigator: 
 
Aravind Arepally, M.D., FSIR 
1984 Peachtree Road  
Suite 505  
Atlanta, Georgia 30309 
 
Co-Principal Investigator  
 
Clifford R. Weiss, M.D 
Interventional Radiology Center 
Department of Radiology 
1800 Orleans Street 
The Johns Hopkins Hospital 
Sheikh Zayed Tower, Suite 7203 
Baltimore, MD 21287 
 
 
 
Aaron Fischman MD 
Asst. Professor of Radiology and Surgery 
1 Gustave Levy Place 
Box 1234, Dept. of Radiology 
Icahn School of Medicine at Mount Sinai 
New York, NY 10029 
 
 
 
Dara L. Kraitchman, V.M.D., Ph.D., F.A.C.C. 
Cardiovascular Interventional Section Head 
Division of MR Research 
Russell H. Morgan Department of Radiology & 
Radiological Science 
Johns Hopkins University 
600 N. Wolfe Street 
Park Building 314 
Baltimore, MD  21287 
 
Rahul Patel MD 
Asst. Professor of Radiology and Surgery 
1 Gustave Levy Place 
Box 1234, Dept. of Radiology 
Icahn School of Medicine at Mount Sinai 
New York, NY 10029 
 
 
Study Monitors: 
 
Clinical Research Center at Johns Hopkins Medical 
Institutes 
 
 
Study Reference Number: 
 
Q130530 
Study Sponsor:  
 
Aravind Arepally, M.D., FSIR 
Division of Interventional Radiology 
Piedmont Healthcare 
 
 

Table of Contents 
 
1 Introduction ........................................................................................................ 4 
1.1 
Study Title .................................................................................................................4 
1.2 
Sponsor ....................................................................................................................4 
1.3 
Background / Clinical Rationale ................................................................................4 
1.3.1 
Stomach is an Endocrine Organ .........................................................................4 
1.3.2 
Anatomy of the Gastric Fundus ..........................................................................4 
1.3.3 
Ghrelin Suppressed after Gastric Bypass Surgery ..............................................5 
1.4 
Study Synopsis .........................................................................................................5 
2 Device Description ............................................................................................. 6 
2.1 
Introduction ...............................................................................................................6 
2.2 
Design ......................................................................................................................6 
2.3 
Regulatory Status .....................................................................................................6 
2.4 
Anticipated Modifications to the Device and Instrumentation .....................................6 
3 Report of Prior Studies ...................................................................................... 7 
3.1 
Pre-Clinical Studies ...................................................................................................7 
3.1.1 
Bariatric Embolization with Sclerosing Agent ......................................................7 
3.1.2 
Bariatric Embolization with Calibrated Spheres ..................................................7 
3.1.3 
Bariatric Embolization with Calibrated Spheres -Histology ..................................8 
3.1.4 
Limitations of Prior Studies .................................................................................9 
3.1.5 
Summary of Animal Studies .............................................................................10 
3.2 
Clinical Studies .......................................................................................................10 
3.2.1 
Bariatric Embolization of Arteries for the Treatment of Obesity:  30 Day Results 
from the Initial IDE Study ..............................................................................................10 
3.2.2 
First in Man presentation at American College of Cardiology ............................13 
3.3 
Bibliography of Published Studies ...........................................................................14 
4 Investigational Plan .......................................................................................... 17 
4.1 
Purpose ..................................................................................................................17 
4.2 
Protocol ..................................................................................................................18 
4.2.1 
Study Design ....................................................................................................18 
4.2.2 
Patient Selection ..............................................................................................18 
4.2.3 
Pre-Treatment  Evaluations and Data Collection ..............................................21 
4.2.4 
Treatment .........................................................................................................23 
4.2.5 
Post-Treatment .................................................................................................24 
4.2.6 
Post-Treatment  Follow-up ...............................................................................24 
4.2.7 
Adverse Events ................................................................................................26 
4.2.8 
Subject Removal from the Study ......................................................................26 
4.3 
Scientific Soundness ...............................................................................................27 
4.3.1 
Study Design ....................................................................................................27 
4.3.2 
Justification of Sample Size ..............................................................................28 
4.3.3 
Statistical Analysis – Endpoint Assessments ....................................................28 
4.3.4 
Data Collection  / Case Report Forms ..............................................................28 
4.3.5 
Adverse Event Reporting ..................................................................................28 
4.3.6 
Data Safety Monitoring Board (DSMB) .............................................................29 

4.4 
Risk/Benefit Analysis ..............................................................................................29 
4.4.1 
Gastric Ulceration from Bariatric Embolization: .................................................29 
4.4.2 
Increased Radiation Dose in Obese Patients....................................................30 
4.4.3 
Non target vascular embolization ......................................................................30 
4.4.4 
Potential Benefits and Study Justification .........................................................31 
4.5 
Administrative and Regulatory Considerations ........................................................31 
4.5.1 
IRB Review.......................................................................................................31 
4.5.2 
Informed Consent .............................................................................................31 
4.5.3 
Confidentiality ...................................................................................................31 
4.5.4 
Monitoring ........................................................................................................32 
4.5.5 
Compliance ......................................................................................................33 
4.5.6 
Training/ Investigator Qualifications ..................................................................33 
4.5.7 
Records Retention ............................................................................................33 
5 Methods, Facilities, and Controls Used for Manufacturing .......................... 34 
6 Investigators ..................................................................................................... 35 
6.1 
List of Investigators .................................................................................................35 
6.2 
Agreement and Certification ....................................................................................36 
7 Institutional Review Boards and Certification ............................................... 42 
8 Promotion ......................................................................................................... 43 
9 Environmental Analysis Report ...................................................................... 44 
10 Labeling .......................................................................................................... 45 
11 Informed Consent Documents ...................................................................... 46 
12 References Cited ............................................................................................... 47 
12 RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM ...................................................................................... 60 
 
 
 

1 INTRODUCTION 
1.1 
Study Title 
Feasibility and Safety Study: Bariatric Embolization for Suppression of Ghrelin Level to Induce 
Weight Loss 
 
1.2 
Sponsor  
Aravind Arepally, M.D., FSIR 
Division of Interventional Radiology, Piedmont Healthcare 
1984 Peachtree Road, Suite 505  
Atlanta, Georgia 30309 
 
1.3 
Background / Clinical Rationale 
1.3.1 Stomach is an Endocrine Organ 
Although there are over 40 hormones that limit food intake, there is only one hormone, ghrelin 
that has been shown to be orexigenic, i.e., to stimulate food intake. Discovered by Kojma et. 
al. in the rat stomach, it was shown to induce growth hormone release by acting on the growth 
hormone secretagogue receptor (GHS-R) in the hypothalamus or anterior pituitary(1). Since 
the identification of this neuropeptide, extensive data in both animals and humans have shown 
its potent orexigenic effects(2). Mechanisms to antagonize or suppress the effects of ghrelin 
on the central nervous system have resulted in dramatic weight loss and change in appetite 
in various studies(2, 3). In studies performed on volunteers, intravenous ghrelin stimulates 
meal initiation, with nearly half of all volunteers describing a sensation of hunger with a 
compensatory increase of 28% in caloric intake(4) . Further evaluation has shown that, in 
humans, there is a consistent pattern associated with ghrelin levels, which rise shortly before, 
and fall immediately after, every meal. In situations such as weight loss, there is a 
compensatory increase in ghrelin levels which may contribute to the difficulty in maintaining 
body weight(5). In obese patients, foods fail to suppress systemic ghrelin levels, which could 
impair postprandial satiety and may initiate overeating. Due to the potent orexigenic effect of 
ghrelin, this hormone has been a target for the treatment of obesity and weight loss. Although 
various reports of ghrelin suppression have been described, none are clinically practical 
 
1.3.2 Anatomy of the Gastric Fundus 
The stomach is classically separated into seven major sections: cardia; fundus; antrum; 
pylorus; lesser curvature; greater curvature; and the angularis (Figure 1A). While each 
section of the stomach has a unique role in the digestive process, the fundus serves as the 
epicenter for the neuroregulatory pathway of the stomach involved with satiety and appetite 
stimulation (6-9). Since ghrelin is expressed mainly in the fundus, it contains 10 to 20 times 
more ghrelin per gram of tissue than the duodenum, the next richest source, and has a higher 
GHS receptor activation than the hypothalamus(10, 11) . Notably, the vascular supply to the 
gastric fundus is distinct, identifiable, and can be accessed with a catheter from a 
percutaneous approach. The dominant flow to the fundus arises from the left gastric artery, 
which is the first branch off the celiac axis (Figure 1B).  

 
In fact, transcatheter gastric arterial embolization has been performed for at least three 
decades and has been shown to be effective at controlling acute gastrointestinal hemorrhage. 
Embolization works by effectively interrupting blood flow. In addition, the GI tract has a  rich, 
collateral blood supply, with extensive vascular arcades that allow for safe embolization 
without ischemia.  Thus, bariatric  arterial embolization (BAE) is already a clinically viable 
procedure and is currently the standard of care in patients whose condition is refractory to 
endoscopic control of gastrointestinal bleeding.   
 
1.3.3 Ghrelin Suppressed after Gastric Bypass Surgery 
More recently, ghrelin appears to have a significant role in the long-term effect of weight loss 
in bariatric surgery. Since bariatric surgery isolates the gastric fundus from ingested nutrients, 
ghrelin profiles are shown to be lower by 77% compared to controls(6, 12-14). Furthermore, 
the normal diurnal pattern is interrupted and the meal-initiated fluctuations are blunted(6, 12) 
. Based on all these findings, achieving low systemic ghrelin levels should become a strategy 
to control obesity and maintain weight loss.  
 
1.4 
Study Synopsis 
This is an Investigator-sponsored clinical investigation.  The purpose of this IDE study is to  
evaluate the safety and feasibility of bariatric embolization as a new minimally-invasive image-
guided therapy for morbid obesity in which specific blood vessels to the stomach are blocked 
in order to suppress the body's signals for feeling hungry, leading to weight loss.  
In this submission, we propose the investigational use of a legally-marketed device for a new 
intended use: the clinical use of calibrated microspheres for bariatric embolization.   Thus, this 
study would be considered physiologic research of the impact of bariatric embolization on the 
systemic hormonal levels of obesity and its impact on weight gain.   
This study will recruit 20  patients in a prospective single arm study to evaluate the feasibility, 
safety  and toxicity of bariatric embolization. This study will be performed jointly at two 
institutions.   
The guiding hypothesis of this study is to prospectively test, that transvascular bariatric 
embolization results in safe and effective weight loss in morbidly obese patients.  The duration 
of the study (time to enrollment of last patient + follow-up period) will be approximately two 
years. 
 
Figure 1A: Anatomic drawing of the 
different sections of the stomach. 
Figure 1B: Vascular supply to the 
stomach. 

2 DEVICE DESCRIPTION  
2.1 
Introduction 
The legally marketed Embosphere Microspheres (Merit Medical., Jordan, Utah) will be used 
to perform the bariatric embolization procedures. 
2.2 
Design 
Embosphere Microspheres are part of a family of embolic materials based on Merit Medical’s 
proprietary microsphere technology. These spheres are designed to offer controlled, targeted 
embolization. 
 
Embosphere Microspheres are biocompatible, hydrophilic, nonresorbable,  microspheres 
produced from an acrylic polymer and impregnated with porcine gelatin. Embosphere 
Microspheres are available in a range of calibrated sphere sizes.. 
The embolization particles are available in six sizes: of 40-120 um, 100-300 um, 300-500 um, 
500-700 um, 700-900 um, and 900-1200 um, to enable appropriate size selection for the tumor 
or malformation to be treated.  Embosphere Microspheres are designed for use under 
fluoroscopic guidance through compatible delivery catheters.  The product is provided as a 
sterile, non-pyrogenic, single use device.   
Additional Embosphere product information can be found at the Merit website 
:http://www.merit.com/products/default.aspx?code=embosphere 
 
2.3 
Regulatory Status 
Device Product Codes:  85 NAJ 
Classification Name:        Artificial Embolization Device 
Regulation Numbers:   
21 CFR 882.5950 
Trade Name:    
 
 
Embosphere Microspheres 
 
 
 
 
 
 
 
 
510(k) Number:   
 
K021397 
Indications for Use: 
Embosphere® Microspheres are indicated for the embolization of 
hypervascular tumors, arteriovenous malformations and uterine 
fibroids. 
2.4 
Anticipated Modifications to the Device and Instrumentation 
There are no anticipated changes to the device during the course of this clinical investigation. 
 

3 REPORT OF PRIOR STUDIES 
3.1 
Pre-Clinical Studies 
These pre-clinical studies were not performed under GLP.  All animal studies were performed 
in a University setting where GLP facilities were not available. 
 
3.1.1 Bariatric Embolization with Sclerosing Agent 
In the initial studies by our group, a direct link 
between the gastric arteries and systemic levels of 
ghrelin has been demonstrated.(15, 16) Using a 
chemical sclerosing agent, sodium morrhuate, to 
selectively ablate the gastric fundus from a 
transarterial approach, ghrelin suppression was 
achieved, probably in part due to the deep 
penetration of liquid embolic agents. In our initial 
studies, Bariatric arterial embolization (BAE) was 
performed in five swine by the selective infusion of 
sodium morrhuate (125 mcg), a chemical 
sclerosing agent, into the gastric arteries that 
supply the fundus(15, 16).  Five controls 
underwent a sham saline procedure.  
 
The pattern of the change in ghrelin levels over 
time was significantly different between control 
and treated animals (p<0.004, Fig 2). In treated 
animals, ghrelin levels were significantly reduced at weeks 1-4 relative to baseline (range 
12.9-42.5% decrease). Control swine continued to gain weight (a 15.1% increase from their 
original weight), whereas BAE-treated swine weights only increased 7.8%. Importantly, non-
target embolization (NTE) was seen frequently in hepatic, splenic, and esophageal arteries in 
almost all animals.  Since these agents are very toxic, extensive tissue necrosis occurred and, 
thus, this agent is not a clinically viable option.   
 
3.1.2 Bariatric Embolization with Calibrated Spheres 
We next tested whether commercially available calibrated microspheres could cause long-
term suppression of systemic ghrelin levels and affect weight gain. In twelve healthy growing 
swine, BAE was performed by the selective infusion of 40µm-calibrated microspheres 
(Celonova Biosciences, San Antonio, Texas)  into the gastric arteries that supply the fundus 
(n=6), while six control pigs received a sham saline injection.  All animals underwent 
endoscopy at three weeks to assess for ulceration or stricture. As anticipated, the average 
weekly change in ghrelin levels was reduced between BAE-treated and control animals and 
reached statistical significance at weeks 1-6 and week 8 (Fig 3), with average post-procedure 
ghrelin values significantly reduced from baseline for treated animals compared to control 
animals (-537.9 pg/dl ± 209.6 vs. 328.9 pg/dl ± 129.0, P = 0.004). In addition, the average 
change in weight was significantly reduced between BAE-treated and control animals and 
reached statistical significance at week 1 and weeks 3-8 (Fig 4). Despite the fact that 
microsphere BAE significantly decreased weight in treated pigs, ulcers were visualized on 
endoscopy and histopathology in treatment animals, i.e., 33% of animals at three weeks. 
Furthermore, almost all ulceration appeared in the stomach antrum, rather than in the gastric 
fundus.  
 
Week 1 
Week 2 
Week 3 
Week 4 
CONTROL 
-1.7% 
-9.7% 
+2.6% 
+ 18.2% 
GACE 
-34% 
-38.6% 
-42.5% 
-12.9% 
 
Fig 2:  Percentage change from baseline in serum ghrelin o
control and BAE swine embolized with sodium morrhuat
(mean+SEM) over a four-week period. In control swine, ther
was no change in systemic ghrelin from baseline until week 4.  I
BAE swine ghrelin decreased at all timepoints with maximum

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.1.3 Bariatric 
Embolization 
with 
Calibrated Spheres 
-Histology  
Tissue 
sections 
in 
control 
animals and 
treatment animals after 
bariatric 
embolization are shown 
in Figures 5 
and 6. After sacrifice at 
eight weeks, 
immunohistochemical 
detection 
of 
ghrelin 
(mouse 
antighrelin 
IgG in a ratio of 1:4000, 
MAB10404, Millipore, Billerica, MA) was determined as the number of positive cells/400X 
high power field.  Ghrelin-immunoreactive cell density was significantly lower in the gastric 
fundus in the treated animals vs. controls (15.3 vs. 22, p=0.001, Fig 5). Yet, ghrelin-
immunoreactive cell density in the duodenum was similar in treated and  control animals 
(8.5 vs. 8.6, p=NS).  
 
 
 
Fig 3: (Left) Mean change 
in ghrelin (over eight 
weeks) in control animals 
vs. swine that underwent 
BAE. (Right) Average 
weekly change in ghrelin 
in control and in animals 
that underwent BAE. 
Ghrelin levels were 
significantly reduced in 
treatment animals at 
weeks 1-6 and week 8. 
*p<0.05 
   
Fig 4: % Change in weight in treated and control 
swine. Weekly mean weight change from 
baseline was significantly different between 
treatment and control animals at weeks 1 and 
weeks 3-8.  *p<0.05 

 
Figure 5.  A, Section of gastric fundus from control animal showing preservation of the mucosa with no evidence of ischemic 
damage (H&E, x100).  B, Immunohistochemical staining for ghrelin from the same area shows several ghrelin expressing 
cells (x100). 
 
 
Figure 6.  A, Section of gastric fundus from a treatment animal showing well-preserved mucosa with minimal ischemic 
damage (H&E, x100).  B,  Immunohistochemical staining for ghrelin from the same area shows a decrease in ghrelin 
expressing cells (x100). 
 
 
All treated animals demonstrated minimal changes in the gastric fundus. This confirms 
that embolization was of adequate extent to induce ischemia, which can be challenging in 
an organ with an extensive collateral arterial supply. However, on gross pathologic and 
histopathologic evaluation of the treatment animals, evidence of healing mucosal ulcers 
was identified in two treated animals, with a healed ulcer identified in one animal. While 
mucosal ulceration is an unwanted effect, the excellent healing response indicates that 
the particle embolization-induced ulcers may be mild and transient without significant long-
term sequelae. 
 
3.1.4 Limitations of Prior Studies 
On three-week endoscopy, ulcers were seen in 2/5 (40%) of our treatment animals. On 
histopathologic analysis of the gastric mucosa after necropsy, ulcers were seen in 2/6 
(33%) treatment animals.  Almost all ulcers have been due to non-target embolization 
since they were seen along the greater curvature and stomach antrum, rather than the 
gastric fundus, which was embolized.  
 
Interestingly, while all treated animals demonstrated minimal to mild ischemia in the 
gastric fundus, there was no evidence of mucosal ulceration of the gastric fundus in any 
B 
A 
B 
A 

treatment animal. This lack of ulceration is most likely due to the rich collateral vascular 
supply to the fundus from multiple sources. Considering that all observed ulcers occurred 
in the lesser curvature and stomach body, this pattern suggests that the injury was related 
to excessive non-target delivery of embolic material at these locations or could represent 
ischemic changes from being a “watershed” territory. Histologically, the infused particles 
were observed throughout the fundus, body, and antrum of the analyzed stomachs, but in 
highest concentration at the gastric fundus. This suggests that the gastric body may be 
more sensitive to ischemia than the gastric fundus, which, in addition to the fact that the 
fundus contains the highest density of ghrelin-expressing cells, further affirms that the 
fundus is the ideal target for bariatric embolization.(17, 18) Further refinement and 
understanding of the vascular anatomy to the stomach and a more directed delivery of 
embolic material to the gastric fundus may reduce the likelihood of developing such gastric 
ulceration patterns. Considering the critical importance of proton pump inhibitors in the 
management of gastric and duodenal ulcers, with which ischemia has been implicated as 
a contributor to pathophysiology, acid reduction may play a role for minimization of ulcer 
development with bariatric embolization 
 
3.1.5 Summary of Animal Studies 
Thus, bariatric arterial embolization significantly suppresses systemic levels of the 
appetite hormone, ghrelin, and affects weight gain without a compensatory up regulation 
of ghrelin-expressing cells in the duodenum.  In summary, our studies indicate that the 
gastric fundus can be embolized using minimally invasive endovascular techniques, and 
results in both a local and a systemic reduction in ghrelin levels with concomitant decrease 
in weight gain in healthy juvenile swine.  Superficial ulcerations were seen in a 33% of 
treated animals but none of these animals were prospectively treated for ulcer prophylaxis.   
 
3.2 
Clinical Studies 
 
3.2.1 Bariatric Embolization of Arteries for the Treatment of Obesity:  30 Day 
Results from the Initial IDE Study 
 
This study was a prospective single arm study to evaluate the feasibility, safety and toxicity 
of bariatric embolization in five obese patients. The primary endpoint of this study is weight 
loss (percentage of excess weight loss [%EWL]) and 30-day Adverse Events.  
 
3.2.1.1 Primary Enpoint (%EWL and Major Adverse Events) 
To date,  five patients with a mean BMI of 43.8 underwent bariatic embolization at 
a single institution.  All patients tolerated the procedure well and the major adverse 
event rate at 30 days was 0%.  At 30 days, the %EWL was 7.6 % (+/- 3.5).  
 
3.2.1.2 Secondary Endpoints:   
At endoscopy, no major gastric ulceration was seen;  one patient  had a small 
minor superficial healing ulcer at the fundus.  Blanching of the fundus was seen in 40%  
(2/5 patients). Nausea/vomiting rate was 60% (3/5 patients). Gastric emptying study 
was normal  at baseline and 4 weeks in all patients.    Eating and hunger/satiety 
assessments showed a significant  decrease in hunger scores. A summary of the 
secondary endpoints are shown below: 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Patient 1 
Patient 2 
Patient 3 
Patient  4 
Patient 5 
Endoscopy 2 wk 
Negative 
Negative (mild 
gastritis) 
Negative, mild 
blanching, no 
ulcers 
mild blanching with 
small superficial 
ulcer 
Mild Blanching 
No ulcers 
Gastric Emptying 
Normal 
Normal 
Normal 
Normal 
Pending 
Lab Changes 
None 
None 
Mildly elevated 
lipase/amylase 
None 
None 
BP Changes 
None 
None 
None 
None 
None 
Hunger Score 
 18 
 86% 
 26% 
Pending 
Pending 
Nausea/Vomiting 
No 
 
No* N: FF/CB 
  
36 hours 
N/V  for 3-4 hours 
  
N/V – 6 hrs 
  
Abdominal Pain 
No 
No 
Resolved after 
36 hours 
No 
No 
Radiation dose 
(mGy) 
4731 
4241 
4671 
6783 
4787 

To date two patients have had full ghrelin analysis using fasting and meal stimulated time 
tests (over 240 minutes).  As shown below, the baseline ghrelin values have been 
suppressed at three months and have had blunted response over time after meal 
stimulation. 
 
 
 
 
 
3.2.1.3 Non-target Ri 
R 
 
3.2.1.4 Risk Benefit Analysis 
In our initial IDE application, we idenfiied three major areas of risk for bariatric 
embolization:  Gastric Ulcers, Increased Radiation Dose in Obese Patients 
and Non Target Vascular Embolization (NTE) 
 
Gastric Ulcers: In order to mitigate the risks for gastric ulcers, gastroprotective 
agents were utilized in all patients.  In addition, all patients were heavily screened 
which seemed to adequately identify all patients that would be at higher risk for 
gastric ulcerations.  Therefore, no major changes will be needed for the protocol. 
 
Radiation Dose:  With radiation dose, the mean dose in this initial study was 
5042.6 (+/- 996) mGy.  There were no associated skin injuries in any patients at 
followup clinic visits.  However, since this study incoroporates cone beam CT to 
minimize the risk of NTE,  this has caused the radiation dose to be slightly 
higher.  We continue to work with imaging vendors to modify fluoroscopic time  
and using software algoriths to reduce radiation exposure.  Furthermore, we 
anticipate that with added technical experience, we anticipate reductions of 
fluoroscopic times for these procedures. 
 
 
NTE:   Due to the proximity of the dorsal pancreatic artery to the left gastric and 
the pancreatico-duodenal arcade to the gastro epiploic, we feel that the risk of 
 

pancreatitis is still one  of our biggest concerns.   In our trial, 3/5 patients 
developed significant nausea/vomiting which may be attributable to reflux.  To 
minimize such reflux and NTE, we now routinely dilute the spheres in a larger 
volume of saline to prevent proximal clumping which can cause reflux. Also, the 
use of 3D CTA prior to the procedure and conebeam CT  was used in all five 
patients to further understand the vascular anatomy.  However due to technical/ 
anatomical challenges, an anti-reflux system was used in only one vessel.  
Moving forward, the use of anti-reflux systems may still be employed to mitigate 
NTE to the pancreas. 
 
 
3.2.1.5 Summary of Intial 5 patient FDA IDE Trial 
 
Bariatric embolization at one month was shown to be safe, effective and well 
tolerated for the treatment of patients with obesity.  Significant decrease in 
hunger scores were noted at one month. 
 
 
 
 
3.2.2 First in Man presentation at American College of Cardiology 
 
Kipshidze N, A.A., Endovascular Treatment of Obesity, First in Man 2013, J Am Coll 
Cardiol. 2013;61(10_S):. doi:10.1016/S0735-1097(13)62056-2: San Francisco. 
 
Background:  Here we provide our preliminary results of the First-In- Man study of Left 
Gastric Artery Embolization (GAE) safety and efficacy in humans. 
 
Methods: 5 patients with different degrees of obesity underwent GAE with BeadBlock 
Embolic Bead 300-500μm microspheres (Biocompatibles UK Limited, Chapman House, 
Farnham Business Park, Weydon Lane Farnham, Surrey, GU9 8QL, UK). 
Esophagogastroscopy was performed in all patients before and after GAE and at 1 week 
follow up to rule out significant initial gastritis or ulcer and any worsening after the 
procedure. Blood Ghrelin level was also measured before the procedure as well as at 1, 
2, 3 and 4 weeks follow up. Observations on Ghrelin levels and patients weight is planned 
at 3, 6 and 12 month follow up. 
 
Results: There was no case of periprocedural complications. 3 of 5 patients complained 
about discomfort in epigastrium during first few hours after procedure, but control 
esophagogastroscopy did not reveal any impairments. All patients reported decreased 
appetite during first week after procedure, Weight loss was observed in all patients at 1 
month follow up: mean initial weight - 128.12+/- 24.4kg was decreased to 114.8+/- 21.3kg 
and mean initial Body Mass Index (BMI) - 42.2 +/- 6.8 was decreased to 37.8+/- 5.7. 6 
moth follow-up results of GAE will be available at time of presentation. 
 
Conclusions: Short term follow up has shown that GAE is safe and feasible. Further 
studies enrolling larger number of patients are planned to confirm these initial findings. 
 
3.2.2  Retrospective Analysis of Left Gastric Embolization in Patients (Scientific 
Sessions RSNA Nov 2013) 

 
 
Gunn, A, Hamilton E. and Oklu, A Catheter to Curb your Appetite? A Novel Observation 
of Weight Loss Following Left Gastric Artery Embolization in Humans 2013, 
Radiological Society of North America. November 2013; Chicago San Francisco. 
 
PURPOSE 
Suppressing serum levels of ghrelin, a neuropeptide with powerful appetite-stimulating 
effects produced in the gastric fundus, is an intriguing potential means of controlling body 
weight. Since left gastric artery, which preferentially supplies the gastric fundus, is 
sometimes embolized in interventional radiology procedures, we assessed post-
procedural weight loss in patients after left gastric artery embolization. 
 
METHOD AND MATERIALS 
Retrospective analysis of electronic medical records of patients who underwent left gastric 
artery embolization for upper gastrointestinal (GI) bleeding were compared to age-
matched controls of similar patients that had undergone embolization of an artery other 
than left gastric artery for upper GI bleeding. Patients were included in the analysi if they 
had a recorded weight within two weeks prior to the embolization and within three months 
after the procedure. Differences in post-procedural weight loss between the groups were 
evaluated by a student's t test. 
 
RESULTS 
Fifteen patients (mean age: 66.1 years) were included in the experimental group analysis 
while eighteen patients (mean age: 63.5 years) were included in the control group 
analysis. The mean pre- and post-procedural weights in the experimental group were 
189.1 lbs and 174.5 lbs, respectively, representing a 7.9% decrease in body weight. The 
mean pre- and post-procedural weights in the control group were 164.7 lbs and 162.8 lbs, 
respectively, representing a 1.2% decrease in body weight. The post-procedural weight 
loss of the nexperimental group was significantly greater than that observed in the control 
group (P=0.001). 
 
CONCLUSION 
Patients lose significantly more weight after left gastric artery embolization than following 
embolization of other arteries for upper GI bleeding. The current data suggests that body 
weight can be potentially modulated via left gastric artery embolization in humans. 
 
 
 
3.3 
Bibliography of Published Studies 
Bariatric Embolization Preclinical Studies (15, 19-23) 
 
 
Arepally, A., et al., Catheter-directed gastric artery chemical embolization for 
modulation of systemic ghrelin levels in a porcine model: initial experience. 
Radiology, 2007. 244(1): p. 138-43. 
 
 
Arepally, A., et al., Catheter-directed gastric artery chemical embolization 
suppresses systemic ghrelin levels in porcine model. Radiology, 2008. 249(1): p. 
127-33. 
 

 
Paxton, B.E., et al., Bariatric embolization for suppression of the hunger hormone 
ghrelin in a porcine model. Radiology, 2013. 266(2): p. 471-9. 
 
 
Bawudun, D., et al., Ghrelin suppression and fat loss after left gastric artery  
embolization in canine model. Cardiovasc Intervent Radiol, 2012. 35(6): p. 1460-6. 
 
 
Madoff, D.C., Science to practice: can transarterial embolotherapy be used as a 
viable alternative to treat obesity? Radiology, 2013. 266(2): p. 369-71. 
 
 
Paxton B , A.C., Crow J, Burchette J , Weiss C,  Kraitchman D, Arepally A , Kim C, 
Histopathologic and Immunohistochemical Sequelae of  Bariatric Embolization in a 
Porcine Model. JVIR, 2013. In Press- JVIR Reference 2754:  
 
Bariatric Embolization: First in Man(24) 
 
 
Kipshidze N, A.A., Endovascular Treatment of Obesity, First in Man 2013, J Am Coll 
Cardiol. 2013;61(10_S):. doi:10.1016/S0735-1097(13)62056-2: San Francisco. 
 
Changes in Obesity Hormones after Bariatric Surgery(17, 25-33) 
 
 
Bose, M., et al., Do Incretins play a role in the remission of type 2 diabetes after 
gastric bypass surgery: What are the evidence? Obes Surg, 2009. 19(2): p. 217-29. 
 
 
Cummings, D.E., Endocrine mechanisms mediating remission of diabetes after 
gastric bypass surgery. Int J Obes (Lond), 2009. 33 Suppl 1: p. S33-40. 
 
 
Goitein, D., et al., Mapping of ghrelin gene expression and cell distribution in the 
stomach of morbidly obese patients--a possible guide for efficient sleeve 
gastrectomy construction. Obes Surg, 2012. 22(4): p. 617-22. 
 
 
Hady, H.R., J. Dadan, and P. Golaszewski, 100 obese patients after laparoscopic 
adjustable gastric banding - the influence on BMI, gherlin and insulin concentration, 
parameters of lipid balance and co-morbidities. Adv Med Sci, 2012. 57(1): p. 58-64. 
 
 
Hady, H.R., et al., The influence of laparoscopic adjustable gastric banding and 
laparoscopic sleeve gastrectomy on weight loss, plasma ghrelin, insulin, glucose 
and lipids. Folia Histochem Cytobiol, 2012. 50(2): p. 292-303. 
 
 
Lee, W.J., et al., Changes in postprandial gut hormones after metabolic surgery: a 
comparison of gastric bypass and sleeve gastrectomy. Surg Obes Relat Dis, 2011. 
7(6): p. 683-90 
 
 
Peterli, R., et al., Metabolic and hormonal changes after laparoscopic Roux-en-Y 
gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg, 
2012. 22(5): p. 740-8. 
 
 
Pirolla, E.H., et al., A modified laparoscopic sleeve gastrectomy for the treatment of 
diabetes mellitus type 2 and metabolic syndrome in obesity. Am J Surg, 2012. 
203(6): p. 785-92. 
 

 
Pournaras, D.J., et al., The gut hormone response following Roux-en-Y gastric 
bypass: cross-sectional and prospective study. Obes Surg, 2010. 20(1): p. 56-60. 
 
 
Roth, C.L., et al., Ghrelin and obestatin levels in severely obese women before and 
after weight loss after Roux-en-Y gastric bypass surgery. Obes Surg, 2009. 19(1): 
p. 29-35. 
 
 
 
 
 

4 INVESTIGATIONAL PLAN 
4.1 
Purpose  
In this submission, we propose the investigational use of a legally marketed device for a new 
intended use: the clinical use of the Embosphere Microspheres (Merit Medical, Jordan UT) for 
bariatric embolization.   Thus, this study would be considered physiologic research of the 
impact of bariatric embolization on the systemic hormonal levels of obesity and its impact on 
weight gain.   
This study is a prospective single arm study to evaluate the feasibility, safety  and toxicity of 
bariatric embolization in 20 obese patients. This study will be performed jointly at two 
institutions.   
The guiding hypothesis of this study is to prospectively test, that transvascular bariatric 
embolization results in safe and effective weight loss in morbidly obese patients.  The duration 
of the study (time to enrollment of last patient + followup period) will be approximately two 
years. 
Study Objectives and Endpoints 
This study will evaluate the feasibility, safety and toxicity of bariatric embolization in 20 
morbidly obese patients at  week 2 and 1, 3, 6 and 12 months.  The primary endpoint of this 
study is the weight loss (absolute weight change from baseline and the percentage of excess 
weight loss [%EWL]) and  30 day Adverse Events.  Currently five patients have already been 
enrolled. 
Patients will be followed for a period of twelve months and study outcomes will be made by 
assessment of: 
 
Weight loss  
 
 
 
 
 
 
 
 
Primary endpoint 
30 Day Adverse Events  
 
 
 
 
 
Primary endpoint 
 
Blood pressure  
 
 
 
 
 
 
 
 
Secondary endpoint 
Lipid Profile 
 
 
 
 
 
 
 
 
 
Secondary endpoint  
Ghrelin levels  
 
 
 
 
 
 
 
 
Secondary endpoint 
Serum obesity hormones 
Leptin, GLP-1, PYY 
 
 
 
 
 
 
Secondary endpoint 
Eating and hunger/satiety assessments  
(Three-Factor Eating Questionnaire scores) Secondary endpoint 
Quality of Life Parameters Survey  
SF-36 and IWQOL-Lite 
 
 
 
 
 
Secondary endpoint  
Food Intake 
 
 
 
 
 
 
 
 
 
Secondary endpoint 
Results from Endoscopy  
 
 
 
 
 
Secondary endpoint 
 
 

4.2 
Protocol 
4.2.1 Study Design 
This study is a prospective single arm study to evaluate the feasibility, safety and toxicity 
of bariatric embolization in 20 obese patients. This study will be performed jointly at two 
institutions.  The guiding hypothesis of this study is to prospectively test, that transvascular 
bariatric embolization results in safe and effective weight loss in morbidly obese patients 
 
Patients will be evaluated at  week 2, and 1, 3, 6 and 12 months following bariatric 
embolization treatment.  A flow chart of the study design is summarized in the following 
table.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2.2 Patient Selection 
 

Subjects who meet the following entrance criteria will provide signed Informed Consent before 
being enrolled into the study. In all animal studies to date, any form of ulceration/gastritis was 
visible by week 1 or 2 at follow-up endoscopy.  As well, no significant ulceration was seen on 
any two week (or later) endoscopy on our first five patients and there was no gastric emptying 
abnormality seen at one month.  Therefore, all patients will undergo follow-up endoscopy at 
week 2  to continue to document procedure safety (see section 4.2.6), but there will be no 
delay as our additional 15  individual subjects will be enrolled at each site. 
 
4.2.2.1 Inclusion Criteria  
 
a) Willing, able and mentally competent to provide written informed consent. 
 
b)  Body mass index (BMI) between 35-60. 
 
c) Residence within 25 miles of the enrolling institution 
 
d) Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion 
of the interventional radiologist amenable to Bariatric Embolization, as assessed 
on 3D CT angiography. 
 
e) Suitable for protocol therapy as determined by the interventional radiology 
Investigator. 
 
f) Adequate hematological, hepatic and renal function as follows: 
 
Hematological 
Neutrophils  
 
> 1.5 x 109/L 
 
 
 
 
Platelets  
 
> 100 x 109/L  
 
 
 
 
INR  
                  <1.5 
 
Hepatic 
 
 
Bilirubin 
 
 
≤ 2.0 mg/dL 
 
 
 
 
Albumin 
 
 
≥ 2.5 g/L 
 
Renal  
 
 
Estimated GFR 
> 60ml/min.1.73m2 
 
g) Aged 18 years to 70 years. 
 
4.2.2.2 Exclusion Criteria  
 
a) Prior history of gastric pancreatic, hepatic, and/or splenic surgery 
 
b) Prior radiation to the upper abdomen 
 
c) Prior embolization to the stomach, spleen or liver 
 
d) Portal venous hypertension 
 
e) Prior  or current history of peptic ulcer disease 
 
f) Large Hiatal Hernia as defined as greater than 5 cm in size. 
 

g) Significant risk factors for peptic ulcer disease including daily NSAID use and 
smoking. 
 
h) Active H. Pylori infection 
 
i) 
Weight greater than 400 pound 
 
j) 
Known aortic pathology such as aneurysm or dissection renal insufficiency as 
evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute 
 
k) Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or 
peripheral arterial disease.  
 
l) 
Complicated arterial anatomic variants including left gastric artery arising from the 
aorta, and/or hepatic arterial supply via a replaced or accessory left hepatic artery 
arising from the left gastric artery. 
 
m) Pregnancy 
 
n) Preexisting chronic abdominal pain 
 
o) Postive stool occult study 
 
p) Abnormal Endoscopy 
 
q) Abnormal Nuclear Gastric Motility examination 
 
r) ASA Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating 
disease that is a constant threat to life) at the time of screening for enrollment into 
the study will be excluded from participation.  This exclusion criterion exists 
because of the possibility that surgical intervention will be needed if the study 
intervention subsequently leads to severe adverse effects.   
 
s) History of Inflammatory Bowel Disease 
 
t) Autoimmune disease 
 
u) Cirrhosis 
 
v) Known history of allergy to iodinated contrast media 
 
w) Failure to comply with pre-procedure weight management “run-in.” 
 
 
 
 
4.2.2.3 Patient Selection – Screening Methods 
 
CT Scan of the Abdomen with 3D CTA 
A contrast enhanced CT scan of the abdomen with 3D CTA will have been completed 
as a routine work-up investigation prior to Bariatric Embolization 

 
Consideration will be given by the interventional radiologist Investigator to the following 
eight vessels and their characteristics in their determination of whether a patient 
possesses vascular anatomy that may be amenable Bariatric Embolization 
 
Eight Mandatory Vessels 
Identified 
(Y/N) 
Origin of Artery 
Superior mesenteric artery 
 
 
Celiac artery 
 
 
Common hepatic artery 
 
 
Right hepatic artery 
 
 
Left hepatic artery 
 
 
Right gastric artery 
 
 
Left gastric artery 
 
 
Gastroduodenal artery 
 
 
 
Screening for Previously Undiagnosed Diabetes 
 
Recruited patients that satisfy the inclusion and exclusion criteria will undergo a 
preprocedural workup, including a detailed history, physical exam, laboratory studies 
(including a glucose tolerance test to evaluate for diabetes or pre-diabetes, and H. 
Pylori serum antibody test) 
 
 
4.2.3 Pre-Treatment  Evaluations and Data Collection 
Recruited patients that satisfy the inclusion and exclusion criteria will undergo the following 
pre-treatment evaluations: 
 
Detailed medical history by Obesity Specialist 
 
Physical exam by Obesity Specialist 
 
Laboratory studies (including a glucose tolerance test, and H. Pylori serum antibody 
test).  These will be performed prior to CTA or endoscopy.) 
 
Hormone testing using a Meal Tolerance Test  
o The meal tolerance test is administered in order to examine the influence of the 
gut hormones on glucose tolerance.  After the placement of a standard IV 
catheter and the collection of baseline samples, the subjects are asked to drink 
Hagen-Daz vanilla ice cream that is put through a blender to get a milkshake 
consistency, 250 cc (in a cup) is given to the participant. They are asked to drink 
it within 15 minutes. Samples are drawn at 5’, 10’, 15’, 20’, 30’, 40’, 60’, 80’, 
100’, 120’, 150’, 180’ and stored at -80ºC in order to measure hormones 
secreted by the alimentary tract.  At each timepoint the subjects will be asked 
to fill out a simple hunger/satiety scale. Phlebotomy for the meal tolerance test 
will not exceed 78 mL. 
 
Upper GI endoscopy 
 
CT Angiography 
 
Nuclear gastric motility examination.  
 
Pregnancy test on the day of or day before procedure. 
 

For the two weeks preceding the procedure, the patients will keep a diet log, and record 
hunger levels, weight, and symptoms. 
 
The results are acceptable for baseline assessment if they were taken within the 30 day 
screening period. The baseline assessments include: 
 
 
Medical history and physical examination including height and weight by obesity 
specialist as a baseline and on all followup visits. 
 
Hemoccult testing 
 
Hematological and biochemical investigations (performed prior to CTA or endoscopy) 
o Complete blood count (CBC) 
o Liver functions tests (LFTs) 
o Serum albumin 
o Electrolytes, urea, creatinine (EUC) 
o Serum or urine pregnancy tests 
o Fasting chemistries, including glucose and insulin  
 
All patients will be assessed by an obesity specialist who will decide: 
 
1. if the patient can tolerate the procedure  
2. there are no absolute contraindications to surgery in the event that surgery 
becomes necessary to address an adverse event.  
3. whether the patient can take omeprazole without causing adverse drug 
interactions or interrupting treatment with their current medications. 
4. All patients will be stratified by standard ASA criteria for surgical risk.  
 
a. Patients who are rated by the screening physician (using standard 
ASA criteria (REF below) as class 4 or 5 (very high risk surgical 
candidates: class 4= incapacitating disease that is a constant threat to 
life) at the time of screening for enrollment into the study will be 
excluded from participation.  This exclusion criterion exists because of 
the possibility that surgical intervention will be needed if the study 
intervention subsequently leads to severe adverse effects.  Class 3 
(patient has severe systemic disease that is not incapacitating) or 
lower-risk patients will not be excluded. 
 
5. Screening for major comorbidities that constitute exclusions from 
participation in the study will be performed at the time of study entry by 
careful review of the patient’s past medical history and current symptoms 
and signs by the obesity specialist.  Standard diagnostic criteria for diabetes 
(ADA 2014), symptomatic coronary artery or valvular heart disease, 
diagnosis of active cancer (except non-mealanoma skin cancer), and 
peripheral artery disease will be used.  Referral for further evaluation and 
treatment will be made as needed.   
 
REF: ADA.  Standards of medical care in diabetes- 2014.  Diabetes Care 37: 
Supp 1: S14-S80, 2014 
 
Saklad 
M. 
Grading 
of 
patients 
for 
surgical 
procedures. 
Anesthesiol. 1941;2:281–4. 

 
Prior to embolization, patients will have a total of 4 visits with a weight management specialist.  
After intake a diet plan will be outlined for the patient and patient will be expected to return for 
3 more visits over 5 weeks.  For the two weeks preceding the procedure, the patients will keep 
a diet log, and record hunger levels, weight, and symptoms. This series of 4 visits is to be 
considered the pre procedural “run-in.” 
 
All patients will also be assessed by an anesthesia provider prior to the procedure that 
patient can tolerate conscious sedation and will not be at any additional risk through the use 
of conscious sedation.  Critical Care Nursing staff, as performed with all embolization 
procedures,  will perform all sedation and monitoring. ECG and arterial oxygen saturation 
will be monitored continuously. Blood pressure and respiratory rates will be measured and 
recorded every 5 min. 
 
 
 
 
4.2.4 Treatment  
4.2.4.1 Medications 
The bariatric embolization procedure will be performed with moderate sedation using 
intravenous midazolam and fentanyl.  All patients will take a daily oral proton pump 
inhibitor (Omeprazole 40 mg) and a daily oral cytoprotective agent (Sucralfate 4g). 
This regimen is based on clinical management of severe duodenal/gastric ulcers for 
six weeks. 
 
4.2.4.2 Procedure 
The subject will be placed supine on the fluoroscopy table.  
 
Vascular access will be achieved using a small 21 gauge needle then dilated serially 
over a guidewire to accommodate a 5 French vascular sheath. Using  standard 
catheters, the arteries supplying the fundus arising off the celiac vessel will be 
selected. Then, a microcatheter will be advanced into the arteries supplying the fundus 
and small calibrated spheres (300-500 micron size) will be infused until stasis of 
anterograde arterial flow is achieved, with particular care to avoid infusion of nontarget 
arteries. Stasis will be defined as visualization of contrast within the target artery for at 
least 5 cardiac cycles.  If an anti-reflux system (Surefire Infusion System) is used, then 
stasis will be evaluated with the tip collapsed.   
 
Upon completion, the catheters will be removed, and hemostasis will be achieved with 
manual compression.   
 
The procedure will be performed with an allowable air kerma limit of 4 Gy (4000 mGy).  
Any patient receiving a greater radiation dose than this will be evaluated for dermal 
injuries during followup, and if necessary undergo additional evaluation and treatment 
by a Dermatologist. 
 
4.2.4.3 Patient Monitoring 
Real-time monitoring of all patient vital signs will be performed per standard protocol 
for interventional radiology procedures during the procedure. 
 

 
 
4.2.5 Post-Treatment  
 
 
Patient will be monitored in the post-sedation recovery room for 4 hours until the 
patient meets usual criteria, followed by overnight hospital admission for observation. 
If it appears clinically indicated (nausea, vomiting etc) the patient may be admitted for 
up to 48 hours post procedure. 
 
All decisions to stop the study in any subject, or the study as a whole will be made by 
a multidisciplinary team. This will include a gastroenterologist, obesity specialist, 
bariatric surgeon and interventional radiologists. Stopping rules that would necessitate 
withdrawal of any individual subject, or of the entire study include the development of 
any of the following conditions during the 6-month period following the procedure in 
any subject: 
 
1. Development of gastric ulceration at the follow up endoscopy that requires any 
form of surgical therapy; If ulceration can be managed medically it will be by Dr. 
Cheskin or Dr. Shin and the patient will remain in the study.  
 
2. Development of any of the following complications will result in stopping the study:  
small bowel obstruction,  hernia, small bowel incarceration, abdominal abscess,  
gastrointestinal bleed, hypotension, new onset cardiac ectopy, bradycardia, 
tachycardia, bowel perforation, pneumothorax, pneumonia, hypoxemia, azotemia, 
heart failure, CO2 narcosis, ventricular bigeminy, pulmonary venous congestion, 
septicemia, shock, ulcer  (anastomotic, peptic), mesenteric venous thrombosis, 
deep vein thrombosis, pulmonary emboli, adhesions, or death. 
 
4.2.6 Post-Treatment  Follow-up 
The patient will continue with recording their diet, hunger levels, weight, symptoms 
(abdominal pain, nausea, cramping, etc) and present for follow up visits at set intervals  
for physical exam and serum blood tests for ghrelin levels over a 12 month period. By 
doing so, we will be able to ascertain the effect of bariatric embolization on patient hunger, 
food intake, symptoms, and serum ghrelin levels in comparison to baseline levels. 
 
The patient will present for clinical follow up with an obesity specialists at  week 1-2 and 
then 1, 3, 6 and 12 month followup.  During each visit, the patient log will be recorded. 
Serum ghrelin testing will be performed. Endoscopic evaluation of the stomach and 
duodenum will be performed at week 2, and 3 month post-embolization to assess for 
development of ulcers that may require additional therapy.  Hormone testing will be 
performed using the Meal Tolerance Test as described above in 4.2.3 – except week 1 
when only fasting labs will be acquired.  At each visit including the 6 month and 1 year 
followup, patient will be evaluated for symptoms of delayed gastric emptying including 
post-prandial pain, nausea and vomiting or early satiety.   
 
Patients will also be scheduled to see a weight management specialist after embolization. 
There will be 16 visits in total with at least one weight management specialist.  This will 
occur during week 1 or 2 and then week 3. From week 4 through 12, the patient will return 

every other week. Example: week 4, 6, 8, 10, 12. After week 12, patient will return at least 
monthly through month 12. 
 
All patients who are women who are able to become pregnant will have a urine pregnancy 
test prior to their gastric emptying study and endoscopy. 
 
Study Calendar 
 
Baseline  Follow-up Assessments:  
First 30 Days  
 
 
 
 
≤ 30 days 
prior  
Day 0:  
 
1-2 week 
 
1 mo 
 
3 mo 
 
6 mo 
12 mo 
Informed consent 
 
 
 
 
 
 
 
Demographics 
 
 
 
 
 
 
 
History 
and 
Assessment 
 
 
 
 
 
 
 
Physical 
exam, 
incl. 
- height & weight 
 
 
 (week1) 
 
 
 
 
SF-36 
IWQOL 
Questionnaire 
 
 
(week1) 
 
 
 
 
Hunger 
Questionnaire 
 
 
(week1)  
 
 
 
 
3D CTA 
 
 
 
 
 
 
 
Gastric Motility 
 
 
 
 
 
Optional 
See 
4.2.7 
 
Endoscopy 
 
 
 (week 2)  
 
 
 
 
 
 
 
 
 
 
 
Bariatric 
Embolization 
 
** 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse events 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lab work 
 
 
 
 
 
 
 
CBC 
 
* 
 Wk 1&2 
 
 
 
 
Hemoccult testing 
 
 
 Wk 1&2 
 
 
 
 
Lipid Profile 
 
 
 Wk 1&2 
 
 
 
 
Ghrelin 
 
 
 Wk 1&2 
 
 
 
 
Leptin, 
GLP-1, 
PPY 
 
 
 Wk 1&2 
 
 
 
 
Glucose Tolerance 
 
 
 
 
 
 
 
Pregnancy test 
 
* 
 
 
 
 
 
Comp Met Panel 
 
* 
 Wk 1&2 
 
 
 
 
PT/INR 
 
* 
 
 
 
 
 
APTT/APTTr 
 
* 
 
 
 
 
 
Hemoglobin A1c 
 
 
 
 
 
 
 
*These labs will be performed if they are > 30 days old.   **Patients may be admitted to the 
hospital for up to 48 after the embolization procedure if deemed clinically indicated. 
* Weight management counseling 4 visits over 5 weeks pre-procedure and 16 more visits post-
procedure 
 

 
4.2.7 Adverse Events 
Adverse events such as mortality, serious complications, minor complications and hospital 
readmission within 30 days of the procedure will be recorded. 
   
Complications (minor or major), were derived under the suggestion of the guidance of the 
American Society on  Metabolic and Bariatric Surgery(34) 
 
Major Complications: Stricture, leak, hematemesis, small bowel obstruction,  hernia, small 
bowel incarceration, gastrointestinal bleed, hypotension, cardiac ectopy, bradycardia, 
tachycardia, bowel  laceration, pneumothorax, pneumonia, hypoxemia, azotemia, heart 
failure, CO2 narcosis, ventricular bigeminy, pulmonary  venous congestion, septicemia, 
shock, ulcer  (anastomotic, peptic), mesenteric venous  thrombosis, deep vein thrombosis, 
pulmonary  emboli, hernia, adhesions, and death. 
 
Minor Complications:  Gout, nausea and  vomiting, dehydration, hypokalemia,  hematoma, 
hypo-/hyperglycemia, ileus,  anastomotic edema, elevated hepatic  transaminases, 
gastroparesis, and abdominal abscess.  
 
Additional endoscopy and gastric emptying examination will be performed on any patient 
who develops symptoms of delayed gastric emptying including post-prandial pain, nausea 
and vomiting or early satiety during the 1 year follow-up period 
 
 
All decisions to stop the study in any subject, or the study as a whole will be made by a 
multidisciplinary team. This will include a gastroenterologist, obesity specialist, bariatric 
surgeon and interventional radiologists. Stopping rules that would necessitate withdrawal 
of any individual subject, or of the entire study include the development of any of the 
following conditions during the 6-month period following the procedure in any subject: 
 
3. Development of gastric ulceration at the follow up endoscopy that requires any 
form of surgical therapy; If ulceration can be managed medically it will be by Dr. 
Cheskin or Dr. Shin and the patient will remain in the study.medical /surgical 
therapy;  
 
4. Development of any of the following complications will result in stopping the study:  
small bowel obstruction,  hernia, small bowel incarceration, abdominal abscess,  
gastrointestinal bleed, hypotension, new onset cardiac ectopy, bradycardia, 
tachycardia, bowel perforation, pneumothorax, pneumonia, hypoxemia, azotemia, 
heart failure, CO2 narcosis, ventricular bigeminy, pulmonary venous congestion, 
septicemia, shock, ulcer  (anastomotic, peptic), mesenteric venous thrombosis, 
deep vein thrombosis, pulmonary emboli, adhesions, or death. 
 
 
4.2.8 Subject Removal from the Study 
Subjects may be removed from the study by the investigator for the following reasons: 
• Staying in the study would be harmful to the subject. 
• The subject needs treatment that is not allowed in the study. 

• It is decided that another therapeutic approach could improve the subject’s     
medical care. 
• The subject fails to follow instructions. 
• The subject is not complying with study visits 
• The study is cancelled. 
• There may be other reasons to remove study subjects that are not known at this 
time. 
 
4.2.9  Subject compensation.  
 
Patients will receive payments up to $1200 after Bariatric Embolization using the 
payment scheme tabulated below: 
 
Week 1-3 
 
Week 4-11  
3-5 Months 
6-11 Months 
12 Months 
Food Log         
$30 
Food Log 
$20 
Food Log 
$20 
Food Log 
$35 
Food Log 
$35 
Hunger Satiety   
$30 
Hunger Satiety 
$20 
Hunger 
Satiety 
$20 
Hunger Satiety 
$35 
Hunger Satiety 
$35 
Meal Test        
$30 
 
Meal Test         
$70 
 
Meal Test      
$70 
 
Meal Test         
$70 
 
Meal Test         
$80 
 
Endoscopy        
$30 
Gastric 
Emptying 
$60 
Endoscopy 
$70 
Gastric Emptying 
$60 
 
 
Weight Mgmt. 
(2 visits).  
$40 
Weight Mgmt. 
(4 visits)  
$80 
Weight 
Mgmt. (3 
visits) $60 
Weight Mgmt. (6 
visits)  
$120  
Weight Mgmt.   
$20 
Basic Labs        
 $10 
 
Basic Labs 
$10 
 
Basic Labs 
$10 
 
Basic Labs 
$15 
 
Basic Labs 
$15 
 
Total             
$170 
Total 
$260 
Total 
$250 
Total 
$335 
Total 
$185 
 
 
 
4.3 
Scientific Soundness 
4.3.1 Study Design 
To ensure that data from sites can be pooled, each site will follow the same protocol, which 
specifies patient selection criteria, treatment procedure, followup requirements, and data 
collection requirements.   

FDA and IRB approvals will be received prior to the implementation of any change to the 
study protocol that may affect the scientific soundness of the investigation or the rights, 
safety or welfare of the patients involved in this investigation. 
4.3.2 Justification of Sample Size 
The purpose of this study is to assess the feasibility and safety of bariatric embolization 
for the suppression of ghrelin levels to induce weight loss 
 
The results of this study will be used to design future pivotal efficacy studies.   The goal 
will be to recruit 20 patients for statistiscal analysis.  
 
Given an expected sustained weight loss of 20 lbs, a sample size of 19 patients would 
give a 80% chance of rejecting the null hypothesis with a P value <0.05 considered 
statistically significant.  Thus, we envision enrolling eventually 20 patients.  
 
4.3.3 Statistical Analysis – Endpoint Assessments 
The primary endpoint will be 30 Day Adverse Events and change in weight from baseline. 
Change in weight will be statistically tested with an analysis of covariance using the 
baseline weight as the covariate. For each patient, the pre-procedure fasting serum 
hormonal levels of ghrelin, leptin, glucose, GLP-1, and PYY will be compared to the post-
procedural serum levels using the Wilcoxon signed rank test to determine whether there 
is a statistically significant decrease in any hormonal parameter.  Hunger scores and 
quality of life  will be similarly compared.  
 
4.3.4 Data Collection  / Case Report Forms 
The investigators will record all pre-procedure, procedural, and post-procedure follow-up 
evaluations and observations including complications and/or adverse effects on the Case 
Report Forms provided by the Sponsor.  All forms when completed will be available for 
inspection by the Sponsor's representative to verify that all necessary information has 
been included and reported accurately.   
The investigator will retain copies of the Case Report Forms.  See appendix A 
An Access database located on the Johns Hopkins Radiology Sharepoint site will track 
study data and patient demographic information. The information will be maintained by 
study members at both sites as well as the Johns Hopkins weight management 
professional.  The Sharepoint site is secured by the Johns Hopkins School of Medicine 
Radiology IT Dept.   
4.3.5 Adverse Event Reporting 
All adverse events: serious (major complications) and non-serious (minor complications) 
and unanticipated adverse events will be recorded on the CRF by the Research 
Coordinators. The Data Safety Monitoring Board (DSMB) will review and determine if each 
adverse event was related to the study.  Additionally, adverse events will be reported to 
the IRBs and FDA, as required. 
 
An investigator shall submit to the Sponsor and to the reviewing IRB a report of any 
unanticipated adverse device effect occurring during an investigation as soon as possible, 
but in no event later than ten working days after the investigator first learns of the effect.  
An investigator shall notify the Sponsor by telephone within 48 hours after the event. 

 
4.3.6 Data Safety Monitoring Board (DSMB) 
The DSMB will be composed of a gastroenterologist, bariatric surgeon, an obesity 
specialist, and an interventional radiologist.  The DSMB will meet on a monthly basis in 
addition to  any meetings regarding any specific event.  All meetings will be documented 
and any problems regarding the study protocol will be immediately relayed to the IRB and 
the FDA.  The principal investigators will be responsible for communicating all reports and 
events to the IRB.   
 
4.4 
Risk/Benefit Analysis 
4.4.1 Gastric Ulceration from Bariatric Embolization:   
To mitigate against gastric ulceration, several technical and clinical approaches will be 
employed.    
 
Technical approach: In all of our prior animal work, small 50 micron beads were utilized 
for bariatric embolization. Since smaller beads are known to have a more distal embolic 
effect, and therefore, the potential for  ischemic ulceration will be higher.  Currently, arterial 
embolization with 100-300 micron particles is routinely clinically performed for a number 
of indications (including embolization of the left gastric artery for control of hemorrhage) 
and has not shown to have significant clinical sequelae of tissue necrosis or infarction.  In 
fact, all the investigators in this trial have embolized the left gastric artery for 
gastrointestinal hemorrhages with larger particles (100-300 micron) and have not seen 
any cases of gastric ulceration/perforation.  Limited clinical experience with bariatric 
embolization has been performed with larger bead sizes.  Therefore,  based upon the 
limited clinical experience and our pre-clinical data, bariatric  embolization with 400 micron 
will be performed.   
 
Clinical methods: In addition to these technical changes, all patients  will be aggressively 
prescreened for gastric  ulcerations including the use of gastric motility examinations, 
baseline upper endoscopy and baseline CT angiography.   Furthermore,  as shown in our 
exclusion criteria, patients that are considered higher risk for ulcerations will be excluded: 
 
Exclusion criteria: 
 
prior history of gastric pancreatic, hepatic, and/or splenic surgery 
 
Prior radiation to the upper abdomen 
 
Prior embolization to the stomach, spleen or liver 
 
Portal venous hypertension 
 
Prior  history of peptic ulcer disease 
 
Significant risk factors for peptic ulcer disease including daily NSAID use and smoking. 
 
Active H. pylori infection 
  
Finally, to further improve the safety profile of this procedure,  gastroprotective agents 
such as oral proton pump inhibitor (omeprazole) and Sucralfate will be utilized. Clinical 
use of proton pump inhibitors (PPI) has significantly influenced the management of acid-
peptic disorders dramatically over the last decade. Three of these agents are now widely 
available; omeprazole (available since 1989), lansoprazole (1995), and pantoprazole 
(1997). These agents selectively and irreversibly inhibit the gastric hydrogen/potassium 
adenosine triphosphatase (H+/K+-exchanging ATPase), part of the 'proton pump' that is 

involved in the final acid secretory process. They thereby inhibit both basal and stimulated 
secretion of gastric acid of parietal cells. Clinical uses include the treatment of peptic ulcer 
disease, gastroesophageal reflux disease, Barrett's esophagus, Zollinger-Ellison 
Syndrome, and the eradication of Helicobacter pylori as part of combination regimens. In 
addition, another typical agent used for ulcer healing is Carafate. This agent works by 
forming a coating over ulcers, protecting the area from further injury.  
 
Therefore, the use of a both systemic therapies such as PPI and a local mucosal agent 
(Carafate) will provide a protective mechanism to the gastric mucosa to minimize gastric 
ulceration. Not only do these agents prevent ulcer formation but also have been shown to 
also improve the healing rates of gastric and duodenal ulcers. Oral proton pump inhibitor 
(Omeprazole 40 mg) and a daily oral cytoprotective agent (Sucralfate 4g) will be taken for 
two weeks prior and six weeks after the procedure in order to protect against gastric ulcers. 
 
 
4.4.2 Increased Radiation Dose in Obese Patients 
 Based upon the pre-IDE discussions,   the procedure will be limited to a cumulative air 
kerma to 4 Gy (4000 mGy). This proposed limit is below the trigger point recommended 
for followup  of patients for skin injuries recommended by NCRP Report No. 168 (5 Gy), 
and  well above the mean dose of 2367 mGy for  treatment of gastrointestinal hemorrhage 
with interventional radiology techniques reported in a multicenter study(35).  Furthermore, 
we are currently in discussion with imaging vendors to provide the latest imaging software 
algorithms that provide ultra low dose imaging during angiography.  Systems with these 
capabilities can reduce radiation up to 60%.    Examples of such systems include the 
Siemens Artis Q.zen or the Philips Clarity IQ technology product line.  When possible, 
such systems will be utilized. 
 
 
4.4.3 Non target vascular embolization 
Because of the variable vascular supply of the stomach and the shared arterial supply with 
other surrounding vital organs, such as the diaphragm, esophagus, liver, spleen, and 
pancreas, there is concern for non target embolization (NTE) due to reflux.   In our 
preclinical animal studies, there was evidence of non-target injury to the body and antrum 
of the stomach due to vascular reflux of embolic spheres.   Because patients who would 
benefit from BAE are generally healthy aside from their obesity, NTE (from either poor 
targeting or reflux) is unacceptable.  To mitigate this NTE three specific technical methods 
will be implemented: 
 
 
a) 3D CT Angiography: Prior to the procedure all patient will undergo a 3D CT 
angiography to not only identify patients with aberrant vascular anatomy but also to 
assess the vasculature to the gastric fundus, antrum and associated adjacent organs 
such as the pancreas, liver and spleen.   
 
b) Cone Beam Computed Tomography (CBCT):   Utilization of  CBCT provides near real 
time  three-dimensional (3D) maps of the gastric and adjacent organ arterial supply 
and CT-like soft tissue contrast, to enable precise targeting to the gastric fundus and 
avoid NTE of nearby critical organs.   
 

c) Anti-reflux infusion microcatheters:  Finally, if feasible, the use of an anti-reflux 
microcatheter (Surefire Medical, Westminister, CO) will be utilized to perform all 
embolizations to eliminate NTE and provide precise targeting of the gastric fundus. 
 
4.4.4 Potential Benefits and Study Justification 
The purpose of this study is to investigate the feasibility and safety of bariatric embolization 
for suppression of ghrelin levels to induce weight loss.  There is no guarantee of specific 
benefit to the patients enrolled in this study. 
 
Data collected in this clinical investigation will provide a foundation for future efficacy 
studies.  
 
4.5 
Administrative and Regulatory Considerations 
4.5.1 IRB Review 
The investigator will provide the Sponsor with documentation that the IRB has approved 
the protocol and informed consent form prior to initiating the trial.   
 
4.5.2 Informed Consent 
Informed consent will be obtained from the subject prior to enrollment in this study. 
 
The informed consent form will conform to 21 CFR 56 and will contain a statement that 
the consent is freely given, that the subject is aware of the risks and benefits of the study 
and that the subject is free to withdraw from the study at any time.  The subject will have 
the opportunity to ask questions and be given time for consideration.   
 
A copy of the signed informed consent will maintained and available for review by the 
Sponsor and their designated monitor. 
 
The investigator is responsible to ensure that informed consent is obtained from each 
subject and for obtaining the appropriate signatures and dates on the consent form.  The 
subject should retain a copy of the signed informed consent. 
 
4.5.3 Confidentiality 
All information regarding patient identification will be kept confidential.  This information 
may be audited by the sponsor and regulatory authorities, and may be inspected and/or 
copied. 
 
Each patient will be assigned a study number.  Study info will be kept in a locked room 
with access limited to individuals participating in the study.  In addition, all data will be 
digitally encrypted 
 
 
All data will be stored on PI’s and research coordinator’s computer with digital encryption 
for 2 years.  Only the primary, co-investigators and research coordinator will have access 
to the data.  The PI will be responsible for receipt and transmission of all data. 
 
All data will be de-identified and stored on a computer with password protection and digital 
encryption of all data on the hard drive.   

 
4.5.4 Monitoring 
4.5.4.1  Monitor 
This study will be monitored by an independent person designated by the sponsor, to 
ensure that the trial is conducted in accordance with the protocol, the signed 
investigator’s agreement, the requirements of 21 CFR 812, and any other conditions 
of approval imposed by the reviewing IRBs and/or FDA. 
 
The monitor for the study will be: 
Lawrence J Cheskin, MD 
Director of Johns Hopkins Weight Management Center HBS 
550 North Broadway, Suite 1001 
Baltimore , Maryland   21205 
 
4.5.4.2 Monitoring Procedures 
 
Selection of the Monitor 
The Monitor is designated by the Sponsor to oversee the investigation.  The Monitor 
will be qualified by training and experience to monitor the investigational study in 
accordance with all applicable regulations. 
General Duties of the Monitor 
The monitor must ensure that the investigation is conducted in accordance with the 
following: 
1. The signed investigator agreement; 
2. The investigational plan; 
3. Any conditions imposed by the IRB or FDA; 
4. The requirements of the IDE regulations (45 FR January 18, 1980, Pp. 8942-8980, 
or 21 CFR Part 812) and other applicable regulations. 
Reports by the Monitor to the Sponsor 
1. Any noncompliance with the items listed above shall be reported to the Sponsor.  
In the event that the investigator is not complying with the requirements outlined 
above, it is the sponsor's responsibility to secure compliance. 
2. Any unanticipated adverse device-related effects shall be reported. 
Initiating the Study 
Prior to initiating the investigation plan, the monitor must conduct a pre-investigational 
visit with each investigator to ensure the following: 
1. The investigator understands and accepts his/her obligation in conducting the 
clinical investigation. 
2. The investigator and his/her staff have sufficient time and access to an adequate 
number of subjects to conduct the clinical investigation. 
3. The investigator has a signed investigator agreement and CV on file. 

4. Each IRB approval is on file, and all conditions of the IRB approval have been met. 
5. The clinical investigation does not begin until FDA notifies the Sponsor in writing 
that the study is approved. 
During the Course of the Investigation 
1. Conduct periodic discussions with the investigator and his/her staff to ensure that 
the study is being conducted in accordance with the protocol or investigational 
plan, any conditions of the IRB, and the requirements of the IDE regulations. 
2. Review case report forms and records to ensure that they are complete, accurate 
and legible. 
3. Review source medical records and case report forms for any serious or 
unanticipated adverse effects. 
F. Records of the Monitor 
The monitor shall prepare and maintain records of each pre-investigational and each 
periodic visit or discussion.  These records will include the following information: 
1. Date, name, and address of the investigator, and names of other staff members 
present at each meeting. 
2. A summary of the findings of the visit. 
3. A statement of any action taken by the monitor or investigator to correct any 
deficiencies noted. 
4. The monitor shall immediately notify the Sponsor of any conditions of 
noncompliance with the protocol, investigational plan, conditions of the IRB or FDA 
approval, or the IDE regulations. 
4.5.5 Compliance 
The Sponsor will monitor compliance to the protocol and appropriate regulations. The 
investigator will not implement any deviation from or add any changes to the protocol 
without agreement by the Sponsor, and prior review and documented approval from the 
FDA and appropriate IRB, except when necessary to eliminate any hazard to trial subjects.  
If compliance is not obtained, the Sponsor reserves the right to terminate the investigator’s 
participation in the trial or to terminate the trial itself. 
 
4.5.6 Training/ Investigator Qualifications 
All investigators will be qualified Interventional Radiologists experienced in the performing 
embolization procedures with the subject devices.  Additionally, the investigators will be 
trained in the protocol, and data collection and record retention requirements. 
 
4.5.7 Records Retention 
The investigator will retain study records for a period of 2 years following the latter of the 
following two dates:  the date on which the investigation is terminated or completed, or the 
date that the records are no longer required for purposes of supporting a premarket 
application.  The Sponsor is to be notified prior to the destruction of any study records. 

5 METHODS, 
FACILITIES, 
AND 
CONTROLS 
USED 
FOR 
MANUFACTURING 
 
The legally marketed Embosphere Microspheres (Merit Medical, Jordan UT) will be used to 
complete the bariatric embolization procedures described in the investistgation plan. 
As this is an Investigator-sponsored IDE, only commercially available Embosphere 
Microspheres, supplied by the manufacturer, will be used in this study. 

6 INVESTIGATORS 
6.1 List of Investigators  
The investigators identified for participation in the study are: 
 
Principal Investigator: 
 
Aravind Arepally, M.D., FSIR 
1984 Peachtree Road  
Suite 505  
Atlanta, Georgia 30309 
 

Co-Principal Investigators: 
 
Clifford R. Weiss, M.D 
Interventional Radiology Center 
Department of Radiology 
1800 Orleans Street 
The Johns Hopkins Hospital 
Sheikh Zayed Tower, Suite 7203 
Baltimore, MD 21287 
 
Dara L. Kraitchman, V.M.D., Ph.D., 
F.A.C.C. 
Cardiovascular 
Interventional Section Head 
Division of MR Research 
Russell H. Morgan Department of 
Radiology and Radiological Science 
Johns Hopkins University 
600 N. Wolfe Street 
Park Building 314 
Baltimore, MD  21287 
 
 
Aaron Fischman MD 
Asst. Professor of Radiology and 
Surgery 
1 Gustave Levy Place 
Box 1234, Dept. of Radiology 
Icahn School of Medicine at Mount 
Sinai 
New York, NY 10029 
 
 
Rahul Patel MD 
Asst. Professor of Radiology and 
Surgery 
1 Gustave Levy Place 
Box 1234, Dept. of Radiology 
Icahn School of Medicine at Mount 
Sinai 
New York, NY 10029 
 
 
 
 
 
 
6.2 
Agreement and Certification 
 
Prior to participating in the study all investigators will sign an Agreement to adhere to the 
protocol and to fulfill other responsibilities as defined in the FDA regulations or in the 
Investigator Agreement. 

 
The Sponsor certifies that all of the investigators who will take part in this study will read and 
sign the Agreement of Investigator's Responsibilities before participating in the study.  No 
investigator will participate in the investigation until they have signed the Agreement. 
 
A copy of the Investigator Agreement is included as Attachment 6A. 

Attachment 6A -Investigator Agreement 
The investigator will provide financial information for up to one year following the study per 
21 CFR 812.43(c)(5). 
 
 
 

 
  CLINICAL INVESTIGATOR AGREEMENT 
Feasibility and Safety Study: 
Bariatric Embolization for Suppression of Ghrelin Level to Induce Weight Loss 
I, _________________________________, agree to participate as a Principal Investigator in the  
clinical investigation: Feasibility and Safety Study: Bariatric Embolization for Suppression of 
Ghrelin Level to Induce Weight Loss 
I agree and/or certify that: 
1. I will conduct the clinical investigation in accordance with this agreement, all requirements of 
the investigational plan, IDE regulations, other applicable regulations of the FDA, and any 
conditions of approval imposed by my reviewing Institutional Review Board (IRB) or FDA.  I 
agree to abide by all of the responsibilities of Investigators addressed under 21 CFR Part 812, 
Subpart E and Subpart G, including but not limited to the following: 
a. I will obtain written approval from the authorized IRB for the institution at which this 
investigation will be conducted. If I am not also the sponsor-investigator of the 
corresponding IDE application, I will submit the certification of IRB approval and any 
conditions of this approval to the sponsor. 
b. I will ensure that Informed Consent is obtained from each subject participating in this 
clinical investigation in accordance with the informed consent regulation found in 21 CFR 
Part 50, and that a signed copy of the informed consent is available to the sponsor  and 
the sponsor’s designated monitor. 
c. I will supervise all testing of human subjects under this protocol and will allow only those 
physician co-investigators listed on the last page of this agreement to administer this 
devices and/or perform follow-up medical evaluations on the device. 
d. I will ensure the accurate completion of protocol case report forms and, if I am not also 
the sponsor-investigator of the corresponding IDE application, I will submit completed 
protocol case report forms, progress reports, and a final report to the sponsor  at the time 
frames specified in the Protocol and/or FDA regulations. 
e. I will direct the retention of required records and documents related to the investigation. 
2. I have the appropriate, relevant qualifications to conduct and to oversee the conduct of the 
clinical investigation as documented by the following:  (Check applicable statement) 
____My relevant qualifications, including dates, location, extent, and type of experience, are 
listed in my most recent curriculum vitae (CV), which is attached to this Agreement and 
which will be maintained by the sponsor (sponsor-investigator) of the corresponding IDE 
application.   
____My curriculum vitae (CV) does not reflect my relevant qualifications, therefore attached 
to this Agreement is a statement of my relevant experience (including dates, location(s), 
extent, and type of experience), which will be maintained by the sponsor (sponsor-
investigator) of the corresponding IDE application. 
3. There are no reasons to question my ability to oversee the appropriate conduct of this clinical 
investigation.  (Check applicable statement.)  

____I have never participated in an investigation or other research activity, which was 
terminated (disqualified) by FDA, the IRB (or equivalent), or sponsor of a study due to a 
non-compliance issue.  
____I have participated in an investigation or other research activity, which was terminated 
(disqualified) by FDA, the IRB (or equivalent), or sponsor of a study due to a non-
compliance issue.  The specific circumstances leading to this termination and my role in 
the respective problems or issues and the resolution of these problems or issues are 
summarized in an attachment to this Agreement. 
4. I further certify that I have not been debarred under the Generic Drug Enforcement Act of 
1992, 21 USC §§ 335a and 335b.  In the event that I become debarred or receive notice of 
an action or threat of an action with respect to my debarment during the term of this 
Agreement, I agree to immediately notify the sponsor (sponsor-investigator) and the 
authorized IRB for my study site.  If I am the sponsor-investigator of the corresponding IDE 
application I will notify the authorized IRB for my study site and the FDA. 
5. As required by 21 CFR Part 54, I will obtain sufficient accurate financial disclosure information 
from all investigators that participate in this clinical investigation in order to submit a complete 
and accurate certification or disclosure statement.  The investigator will provide financial 
information for up to one year following the study per 21 CFR 812.43(c)(5). 
 
PRINCIPAL INVESTIGATOR 
________________________________ 
Name of Principal Investigator (please print or type) 
___________________________________________ 
Office (Mailing Address) 
_______________________________ 
_______________________________ 
City/State/Zip 
E-mail 
_______________________________ 
_______________________________ 
Telephone 
FAX 
_______________________________ 
_______________________________ 
Signature of Principal Investigator 
Date 
Sub-INVESTIGATORS:  (i.e., research fellows, residents, associate) who will be assisting the 
investigator in the conduct of the investigations.   
_______________________________ 
Name of the Sub-Investigator (please print or type) 
_______________________________ 
_______________________________ 
Signature 
Date 

_______________________________ 
 
 

7 INSTITUTIONAL REVIEW BOARDS AND CERTIFICATION 
 
The clinical study will be conducted at a maximum of 3 clinical sites.  The address and 
chairmen of the institutional review boards of the currently identified sites are given below: 
 
Jeffrey Silverstein, MD, CIP 
Executive Director; IRB Chair 
Program for Protection of Human Subjects 
Icahn School of Medicine 
One Gustave L. Levy Place 
Box 1081 
New York, NY 10029-65749 
Tel: 212-824-8200 
E-mail: jeff.silverstein@mssm.edu 
 
Howard Lederman M.D., Ph.D. 
Johns Hopkins Medical Institutes 
East Baltimore Campus (Central Office) 
1620 McElderry St., Reed Hall - B130, Baltimore, MD 21205-1911 
 
 
The investigational plan has not yet been submitted to any institutional review boards.  The 
Sponsor certifies that the study will not begin at any site until the FDA IDE approval and IRB 
approval has been obtained. 
 
 
 

8 PROMOTION 
The legally marketed Embosphere Microspheres (Merit Medical, Jordan UT) will be used to 
complete the bariatric embolization procedures described in the Investigational Plan. 
This is an Investigator-sponsored clinical investigation.  The Sponsor-Investigator and 
Principal Investigators will not promote the device for the investigational use which is the 
subject of this Investigational Device Exemption.  
 
There will be no charge to the patient for the investigational device during the study. 
 
 
 

9 ENVIRONMENTAL ANALYSIS REPORT 
 
The legally marketed Embosphere Microspheres (Merit Medical, Jordan UT) will be used to 
complete the bariatric embolization procedures described in the Investigational Plan.  
 
The Sponsor-Investigator claims that this application for an Investigational Device Exemption 
is exempt from the requirement to prepare an Environmental Impact Analysis.   
 
 
 
 

10 LABELING 
 
This is an Investigator-sponsored investigation of the legally-marketed Embosphere 
Microspheres (Merit Medical, Jordan UT).    
 
No changes will be made to the labeling by the Sponsor-Investigator. All beads that are 
obtained from the manufacturer will label the study inventory by the research coordinator: 
 
Caution: Investigational Device. Limited by Federal law to investigational use.* 
*Applies to use of this device in the study: “Feasibility and Safety Study: Bariatric Embolization 
for Suppression of Ghrelin Level to Induce Weight Loss” 
 
 
 

11 INFORMED CONSENT DOCUMENTS 
 
Patients will be provided with a full explanation, in lay terms, of the aims of the study and the 
potential benefits as well as the possible side effects and risks involved. It will be explained 
that they may refuse to take part in, or withdraw from the study without prejudice to their future 
care and treatment. 
 
Written informed consent must be obtained from all patients prior to study entry. The consent 
form must be filed in the patient record. Consent to participate in this study will be obtained 
from the patient both verbally and in writing. In the case where the patient is not fluent in 
English an interpreter must be present during the obtaining of consent. Patients will be issued 
with a copy of the information provided and their consent to participate in the study. All 
informed consent forms used in this study must be approved by the relevant IRB and by the 
study Sponsor. 
 
 
A copy of the model Informed Consent Document can be found in Appendix B. 
 
 

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10.2478/v10039-012-0008-8. PubMed PMID: 22440938. 
27. Hady HR, Golaszewski P, Zbucki RL, Dadan J. The influence of laparoscopic adjustable 
gastric banding and laparoscopic sleeve gastrectomy on weight loss, plasma ghrelin, 
insulin, glucose and lipids. Folia histochemica et cytobiologica / Polish Academy of 

Sciences, Polish Histochemical and Cytochemical Society. 2012;50(2):292-303. PubMed 
PMID: 22763970. 
28. Lee WJ, Chen CY, Chong K, Lee YC, Chen SC, Lee SD. Changes in postprandial gut 
hormones after metabolic surgery: a comparison of gastric bypass and sleeve 
gastrectomy. Surgery for obesity and related diseases : official journal of the American 
Society for Bariatric Surgery. 2011;7(6):683-90. doi: 10.1016/j.soard.2011.07.009. 
PubMed PMID: 21996600. 
29. Peterli R, Steinert RE, Woelnerhanssen B, Peters T, Christoffel-Courtin C, Gass M, et al. 
Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve 
gastrectomy: a randomized, prospective trial. Obes Surg. 2012;22(5):740-8. doi: 
10.1007/s11695-012-0622-3. PubMed PMID: 22354457; PubMed Central PMCID: 
PMC3319900. 
30. Pirolla EH, Jureidini R, Barbosa ML, Ishikawa LC, Camargo PR. A modified laparoscopic 
sleeve gastrectomy for the treatment of diabetes mellitus type 2 and metabolic syndrome 
in 
obesity. 
American 
journal 
of 
surgery. 
2012;203(6):785-92. 
doi: 
10.1016/j.amjsurg.2011.08.014. PubMed PMID: 22409993. 
31. Pournaras DJ, Osborne A, Hawkins SC, Mahon D, Ghatei MA, Bloom SR, et al. The gut 
hormone response following Roux-en-Y gastric bypass: cross-sectional and prospective 
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19826888. 
32. Roth CL, Reinehr T, Schernthaner GH, Kopp HP, Kriwanek S, Schernthaner G. Ghrelin 
and obestatin levels in severely obese women before and after weight loss after Roux-en-
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x. PubMed PMID: 18521699. 
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PMID: 12817038. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

APPENDIX A- CASE REPORT FORMS 
 
Feasibility and Safety Study: Bariatric Embolization for 
Suppression of Ghrelin Level to Induce Weight Loss 
 
Center: □ Johns Hopkins  
□ Mt. Sinai  
 
 
  
 
Patient number ______________________ Patient initials 
__________________________ 
 
Screening information 
Informed consent signed? □ Yes □ No  Date of informed consent 
___________________ 
 
Inclusion Criteria 
NB: A response of “no” means that the patient is not eligible for this study 
Yes 
No 
a. Willing, able, and mentally competent to provide written informed consent 
□ 
□ 
b. Body mass index (BMI) between 40-60 
□ 
□ 
c. Residence within 25 miles of the enrolling institution 
□ 
□ 
d. Hepatic vascular anatomy that in the opinion of the interventional 
radiologist amenable to Bariatric Embolization, as assessed on 3D CT 
angiography. 
□ 
□ 
e. Suitable for protocol therapy as determined by the interventional radiology 
Investigator. 
□ 
□ 
f. Adequate hematological, hepatic and renal function as follows: 
 
 
   Neutrophils  > 1.5 x 109/L  
□ 
□ 
   Platelets > 100 x 109/L 
□ 
□ 
   Bilirubin ≤ 2.0 mg/dL 
□ 
□ 
   Albumin ≥ 2.5 g/L 
□ 
□ 
   Estimated GFR> 60ml/min.1.73m2 
□ 
□ 
   INR<1.5 
□ 
□ 
g. Age 18 years to 70 years. 
□ 
□ 
 
Exclusion Criteria 
NB: A response of “yes” means that the patient is not eligible for this study 
Yes 
No 
a. Prior history of gastric pancreatic, hepatic, and/or splenic surgery 
□ 
□ 
b. Prior radiation to the upper abdomen 
□ 
□ 
c. Prior embolization to the stomach, spleen or liver 
□ 
□ 
d. Portal venous hypertension 
□ 
□ 
e. Prior history of peptic ulcer disease 
□ 
□ 
f.  Large Hiatal Hernia, greater than 5 cm. 
 
 
g. Significant risk factors for peptic ulcer disease including daily NSAID use 
and smoking.  
□ 
□ 
h. Active H. Pylori infection 
□ 
□ 
i. Weight greater than 400 pounds 
□ 
□ 
j. Known aortic pathology such as aneurysm or dissection renal insufficiency 
as evidenced by an estimated glomerular filtration rate of < 60 milliliters per 
minute 
□ 
□ 

k. Major comorbidity such as cancer, significant cardiovascular disease, 
diabetes, or peripheral arterial disease.  
□ 
□ 
l. Complicated arterial anatomic variants including left gastric artery arising 
from the aorta, and/or hepatic arterial supply via a replaced or accessory left 
hepatic artery arising from the left gastric artery. 
□ 
□ 
m. Pregnancy 
□ 
□ 
n. Preexisting chronic abdominal pain/discomfort 
□ 
□ 
o. Positive stool occult study 
□ 
□ 
p. Abnormal Endoscopy 
□ 
□ 
q. Abnormal Nuclear Gastric Motility examination 
□ 
□ 
r. ASA Class 4 or 5 
□ 
□ 
s. History of Inflammatory Bowel Disease 
□ 
□ 
t. Autoimmune Disease 
□ 
□ 
u. Cirrhosis 
□ 
□ 
v.Known history of allergy to iodinated contrast media 
 
□ 
□ 
 
Baseline Visit 
 
Date of visit: ________________ 
 
Age 
 
Gender 
□ Male   □ Female 
Ethnicity 
□ White / Caucasian 
□ Black / African American 
□ Hispanic / Latino 
□ Asian 
□ Other, specify ___________________________ 
Height 
 
Weight 
 
Body mass index 
 
Blood pressure 
 
Heart rate 
 
If female, has a pregnancy 
test been performed? 
□ Yes    □ No    □ N/A 
     If yes, date of test 
 
     If yes, pregnancy test 
result 
□ Negative     □ Positive (ineligible) 
Prior weight-loss attempts: 
□ Diet 
□ Exercise regimen 
□ Medications, list: _________________________ 
□ Psychotherapy 
 

 
 
 
 
 
 

 
 
 

Baseline laboratory analysis  
 
Date performed 
_______________________ 
 
Test 
value 
required range 
meets criteria? 
Hematocrit 
 
 
 
White Blood Cell 
Count 
 
 
 
Neutrophil count 
 
> 1.5 x 109/L 
□ yes    □ no 
Platelet count 
 
> 100 x 109/L 
□ yes    □ no 
AST 
 
 
 
ALT 
 
 
 
Bilirubin 
 
≤ 2.0 mg/dL 
□ yes    □ no 
Albumin  
 
≥ 2.5 g/L 
□ yes    □ no 
Sodium 
 
 
 
Potassium 
 
 
 
Chloride 
 
 
 
BUN 
 
 
 
Creatinine 
 
 
 
Estimated GFR 
 
> 60mL/min.1.73m2 
□ yes    □ no 
Glucose 
 
 
 
Insulin 
 
 
 
Serum Ghrelin 
 
 
 
Serum Leptin 
 
 
 
Serum GLP-1 
 
 
 
Serum PPY 
 
 
 
Total cholesterol 
 
 
 
Low-density 
lipoprotein 
 
 
 
High-density 
lipoprotein 
 
 
 
Triglyceride level 
 
 
 
Glucose tolerance 
 
 
 
 
 
  

Baseline contrast-enhanced 3D CTA  
Date performed 
_______________________ 
 
Eight Mandatory Vessels 
Identified 
(Y/N) 
Origin of Artery 
Superior mesenteric artery 
 
 
Celiac artery 
 
 
Common hepatic artery 
 
 
Right hepatic artery 
 
 
Left hepatic artery 
 
 
Right gastric artery 
 
 
Left gastric artery 
 
 
Gastroduodenal artery 
 
 
 
 
Baseline endoscopy   
 
Date performed _________________________ 
 
Findings  
 
Gastritis? 
□ no   □ yes –location: 
Ulcers? 
□ no   □ yes –location: 
Other findings:  
(list) 
 
 
 
 
 
Baseline gastric motility 
 
Date performed _________________________ 
 
Transit time: __________________________ 
 
 
Baseline hunger survey  
 
Date performed _________________________ 
 
Hunger score: _________________________ 
 
 
 

Bariatric embolization procedure 
 
Date performed 
_________________________ 
 
Findings  
 
Technical success? 
□ yes   □ no 
Contrast volume 
used 
 
Radiation dose 
 
Periprocedural 
complications?  
□ yes   □ no  
If yes, please describe:  
 
 
Use of Surefire 
Infusion System 
□ yes   □ no 
 
Target Vessel 
Stasis 
 
 
 
□ yes   □ no 
Volume of Beads 
used 
 
 
 
 
Vessel Embolizaed 
□ Left Gastric   □ Gastroepiploic  □ Other :  
 
Target Vessel 
Stasis 
 
 
 
□ yes   □ no 
Volume of Beads 
used 
 
Use of Surefire 
Infusion System 
 
 
 
Vessel Embolizaed 
□ Left Gastric   □ Gastroepiploic  □ Other :  
 
Target Vessel 
Stasis 
 
 
 
□ yes   □ no 
Volume of Beads 
used 
 
Use of Surefire 
Infusion System 
 
 
 

 
Vessel Embolizaed 
□ Left Gastric   □ Gastroepiploic  □ Other :  
 
Target Vessel 
Stasis 
 
 
 
□ yes   □ no 
Volume of Beads 
used 
 
Use of Surefire 
Infusion System 
 
 
 
 
 

Follow-up visit 
 
Interval  
□ 1month 
□ 3month 
□ 6 month 
□ 12 month 
Ethnicity 
□ White / Caucasian 
□ Black / African American 
□ Hispanic / Latino 
□ Asian 
□ Other, specify ___________________________ 
Weight 
 
Body mass index 
 
Blood pressure 
 
Heart rate 
 
Endoscopy results 
□ negative   □ gastritis    □ ulcers     
Gastric motility time 
 
Hunger score 
 
Compliant with omeprazole 
and sucralfate? 
□ yes   □ no 
Lab results 
 
Glucose tolerance 
□ Negative     □ Positive (ineligible) 
Serum Ghrelin 
 
Serum Leptin 
 
Serum GLP-1 
 
Serum PPY 
 
Total cholesterol 
 
Low-density lipoprotein 
 
High-density lipoprotein 
 
Triglyceride level 
 
Glucose tolerance 
 
 
 

Adverse Event (AE) 
Report 
 
Adverse event type 
□ mortality   □ major complication  □ minor complication 
Adverse event 
description 
 
AE start date 
 
AE stop date 
 
Action taken? 
□ Continued study protocol   
□ Study protocol altered   
□ Study protocol terminated  
Treatment given? 
□ None   □ Medications, specify   □ Other, specify: 
 
 
 
Outcome 
□ Resolved w/sequelae  □ Resolved, no sequelae  □ Ongoing  
□ Death 
Is event related to 
bariatric embolizaton? 
□ No   □ Unlikely □ Possible  □ Probable  □ Definite 
 
Periprocedural 
complications?  
□ yes   □ no  
If yes, please describe:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
APPENDIX B- DRAFT INFORMED CONSENT DOCUMENT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12 RESEARCH PARTICIPANT INFORMED CONSENT AND 
PRIVACY AUTHORIZATION FORM 
 
Protocol Title:  
Safety and Feasibility of Bariatric Embolization for 
Suppression of Ghrelin Level to Induce Weight Loss 
 
Application No.:  
xxxxxx 
 
Sponsor:  
XXXXX 
 
Principal Investigator: 
 
 
 
Aravind Arepally, M.D., FSIR 
Physical Address:  
Division of Interventional Radiology, Piedmont Healthcare 
1984 Peachtree Road, Suite 505 
Atlanta, Georgia 30309 
Phone: 404-561-6153 
 
  
 
1. 
What you should know about this study: 
 You are being asked to join a research study. 
 This consent form explains the research study and your part in the study.   
 Please read it carefully and take as much time as you need.  
 Please ask questions at any time about anything you do not understand.   
 
 
 
 
 
 
 
 
                               Patient I.D. Plate 

 You are a volunteer.  If you join the study, you can change your mind later. You 
can decide not to take part or you can quit at any time. There will be no penalty or 
loss of benefits if you decide to quit the study.   
 During the study, we will tell you if we learn any new information that might 
affect whether you wish to continue to be in the study. 
 Ask your study doctor or the study team to explain any words or information in 
this informed consent that you do not understand. 
 For clinical trials: A description of this clinical trial will be available at 
www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include 
information that can identify you. At most, the Web site will include a summary 
of the results. You can search the Web site at any time. 
 If you have clinical tests done as part of this research study, a statement will be 
added to your medical record that you are in this research study. Results from any 
clinical tests you have will be included in your medical record.  Doctors outside 
of this research institution may not have access to this information.  You can ask 
the research team to send this information to any of your doctors. 
 
2. 
Why is this research being done? 
 
The purpose of this study is evaluate the safety and feasibility of bariatric embolization 
as a new minimally-invasive image-guided therapy for morbid obesity.  In this 
procedure specific blood vessels to the stomach are blocked in order to suppress the 
body's signals for feeling hungry, leading to weight loss. 
Morbid obesity is currently treated with diet and exercise, medications, and with 
surgery. This study is designed to test the first procedure designed to help treat obesity 
using a minimally invasive, non-surgical, angiographic (through the blood vessel) 
approach. 
Although there are over 40 hormones that limit food intake, there is only one 
hormone, ghrelin that has been shown to be to stimulate food intake.  In obese 
patients, eating fails to suppress ghrelin levels, which is believed to prevent feeling 
full after a meal and to initiate overeating. Due to the potent hunger inducing effects 
of ghrelin, this hormone has been a target for the treatment of obesity and weight 
loss. More recently, ghrelin appears to have a significant role in the long-term effect 
of weight loss in bariatric (obesity) surgery where ghrelin levels are shown to be 
much lower when compared to untreated patients.   
 
Recent data collected in both animals and in patients in small, short–term studies 
has demonstrated that blocking blood vessels (embolization) to particular portion of 
the stomach can temporarily suppress systemic levels of the appetite inducing 
hormone, ghrelin, leading to a prevention of short-term weight gain in animals. This 
procedure is an adaptation of a commonly performed procedure used to treat 
bleeding within the stomach. This adapted procedure has been named “bariatric 
embolization”. 
The guiding hypothesis of this study is to test that bariatric embolization results in safe 
and effective weight loss in morbidly obese patients. Bariatric embolization uses 

devices cleared for embolization of highly vascular tumors or certain vascular 
malformations, but their use in the stomach to cause weight loss is investigational. 
You may qualify to take part in this research study if you are morbidly obese and your 
physician has suggested bariatric surgery. 
 
How many people will be in this study? 
Twenty (20 )  people are expected to participate in this study at both sites.  
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things: 
 
Screening and pre-procedure assessment 
 
Prior to being enrolled in the bariatric embolization trial, you will have a 
screening evaluation which will include the following exams, tests and 
procedures: 
 Detailed medical history 
 Physical exam 
 Laboratory studies (including a glucose tolerance test, and H. Pylori 
serum antibody test) 
 Upper GI endoscopy 
 CT Angiography 
 Nuclear medicine gastric motility/emptying examination 
 
 
If you qualify for this trial:  within 30 days of the procedure you will undergo a 
baseline assessment which will include:   
 
Medical history and physical examination including height and 
weight 
 Hematological and biochemical investigations 
o Complete blood count (CBC) 
o Liver functions tests (LFTs) 
o Serum albumin 
o Electrolytes, urea, creatinine (EUC) 
o Serum or urine pregnancy tests 
o Fasting chemistries, including glucose and insulin , and 
gastric hormones (including Ghrelin) 
 
For the two weeks prior to the procedure, you will be asked to keep a diet log, 
and record hunger levels, weight, and symptoms. 
 
It is very important that you tell your doctor about all medication you are 
taking before receiving any research intervention(s). This includes 
prescription medication and over the counter medications such as cough and 
cold remedies, pain relievers, and antacids.  Use of illegal drugs during 

participation in this study is strictly forbidden and will result in you being 
discontinued from the study. Please ask your doctor if you have any 
questions about anything that you take.  
 
Pre- and Post Procedure Medications: 
You will be asked to take a daily oral proton pump inhibitor (Omeprazole 40 
mg) and a daily oral cytoprotective agent (Sucralfate 4g). for two weeks prior 
and six weeks after the procedure in order to protect you against gastric ulcers. 
 
Bariatric Embolization Procedure: 
The bariatric embolization procedure will be performed with moderate sedation 
using intravenous midazolam and fentanyl . 
 
 This procedure will take about 1 ½-3 hours. 
 You will be placed on the X-ray fluoroscopy table. 
 Next you will receive local anesthesia in the skin of your leg, then a different 
small catheter (thin tube) will be placed through the skin of your upper thigh into 
an artery that leads to your abdomen.   
 Contrast (x-ray dye) will be injected through the catheter so your doctor can see 
all the blood vessels (angiogram) that bring blood to your stomach with an 
imaging machine (called fluoroscopy).   
 Then the catheter will be directed the artery feeding the top of your stomach 
(fundus) and small particles will be slowly infused into the artery(ies) to block off 
blood flow to the fundus.  
 After the particles have been delivered the catheter will be removed from your leg  
and your artery will be closed, and pressure will be applied to the area.  
 
Follow-Up Visits 
You will be asked to continue recording your diet, hunger levels, weight, 
symptoms (abdominal pain, nausea, cramping, etc) and present for follow up 
visits at set intervals for physical exam and serum blood tests for ghrelin levels 
over a 12 month period.  You will be asked to present at one week and then 1, 
3, 6 and 12 month for follow-up.  During your 1 month visit and for each visit 
thereafter, your log will be recorded, a physical exam will be performed and you 
will be asked to fill out questionnaires. Blood testing will be performed. 
Endoscopic evaluation of the stomach and duodenum will be performed at 1 
week, 1 month, and 6 month post-embolization.   A nuclear medicine gastric 
motility study may be performed at 1 month and at 6 months if the baseline 
endoscopy is abnormal.  
 
Incidental Findings: 
A qualified person will review the CTA you are having as part of this research 
study just as it would be if you were having the MRIs as part of your routine 
medical care. 
 

There is a possibility that while reviewing your CTA we may see an 
abnormality that we did not expect to see in this study. This is what is called 
an “incidental finding.” 
 
We will let you know if we see such an incidental finding.  Depending on the 
type of incidental finding, we may contact you by mail or by phone. In the 
case of a potential serious emergency, someone may go to your home. 
 
A qualified person (usually a member of the research team) will talk to you if 
there is an incidental finding. You do not have an option to decline information 
about an incidental finding. 
 
If you want, we will give information about this incidental finding to your 
primary doctor or we will refer you to an appropriate doctor for further 
evaluation. 
 
An incidental finding may cause you to feel anxious.   
 
Since an incidental finding will be part of your medical record, you 
could face greater difficulty in getting health or life insurance.  
 
The costs for any care that will be needed to diagnose or treat an 
incidental finding would not be paid for by this research study.  These 
costs would be your responsibility. 
 
Future Contact 
We would like your permission to contact you about other studies that you 
may be eligible for in the future. 
 
Please initial your choice below: 
 
 Yes, you may contact me in the future about other studies. 
 No, I do not want you to contact me about other studies. 
 
How long will you be in the study? 
You will be in this study for up to 2 years. 
 
4. 
What are the risks or discomforts of the study? 
There are certain risks and discomforts that may be associated with this 
research study.    Previous studies have shown the side effects to be: 
 
Bariatric embolization procedure 
Possible side effects may result from particles lodging into areas outside the targeted 
stomach area (called non targeted embolization), resulting in blockage of the blood 
vessels to the bowel, liver, gallbladder, pancreas, spleen, groin, bladder, pelvis or 
legs. If severe, this might require surgery to correct.   
 
Other possible events include nausea, vomiting, inflammation of the stomach, 
ulceration, or bleeding from the stomach.  Stomach rupture or death from this 
procedure is also possible.  Bleeding from the area in your thigh where the catheter 

goes in, allergic reaction to contrast agent or microspheres, an effect on fertility,  
damage (perforation) to a blood vessel which could lead to hemorrhage, a temporary 
contraction in a blood vessel (vasospasm), bruise in the groin area (inguinal 
hematoma), or injury from radiation exposure during imaging.  
 
Blood clots in your veins (deep vein thrombosis) or lungs (pulmonary embolism) or 
death are unlikely but possible. 
 
Angiography 
An angiogram is a procedure in which a catheter (long narrow tube) is guided from a 
blood vessel in the leg (common femoral artery) into the blood vessels of the prostate 
artery to inject contrast (imaging dye) so your doctor can see the blood vessels.     
 
Potential side effects include groin soreness and bruise formation, damage to or 
spasms (contractions) in the blood vessels as a result of guidewire and catheter 
manipulation that results in failure to treat the prostate, formation of a blood clot 
resulting in blockage of a blood vessel, infection,  allergy to contrast agent or injury 
from radiation exposure during imaging.  
 
Radiation Exposure: 
This research study includes exposure to radiation from x-rays or gamma-rays (CT 
scan, gastric-emptying study, Bariatric Embolization). This radiation exposure is for 
research purposes only and is not part of your medical care. X-rays and gamma rays 
can damage the genetic material (DNA) in cells. At low doses, cells usually can repair 
this damage. There is some possibility that an incorrect repair may increase the risk of 
cancer in your lifetime. The normal lifetime risk of cancer is 25%. A radiation dose of 
15 rems (a rem is a unit of radiation dose) would increase your lifetime risk to 25.6%. 
Additionally should you become pregnant prior to any of these three studies there 
would be unforeseen risks to you and/or your embryo. 
 
The radiation exposure that you will get in this research study is approximately 6500 
mrem. To put that in context, the average person in the United States gets a radiation 
exposure of 0.3 rem per year from natural sources, like the sun, outer space, air, food 
and soil. People who work with radiation (for example, x-ray technologists) are 
allowed a maximum exposure of 5.0 rem each year. Although these levels of 
radiation are thought to cause an increased risk of cancer, studies in people who work 
with radiation have rarely shown a measurable increase in cancer risk.  
The radiation exposure described here is what you will get from this research study 
only. It does not include any exposure you may have received or will receive from 
other tests outside of this study that are a part of your medical care.  Radiation risk 
builds up with each exposure. You should think about your own history of radiation 
exposure from tests (like x-rays or CT scans) in deciding about the radiation in this 
study. If you have questions about the total amount of radiation you will be receiving, 
you should ask your doctor. 
 
Endoscopy: 

Upper endoscopy is a very safe procedure. However it carries a very small risk of 
complications. Rare complications include: 
Bleeding. Your risk of bleeding complications after endoscopy is increased if the 
procedure involves removing a piece of tissue for testing (biopsy) or treating a 
digestive system problem. In rare cases, such bleeding may require a blood 
transfusion.  
Infection. Most endoscopies consist of an examination and biopsy, and risk of 
infection is low. The risk of infection increases when additional procedures are 
performed as part of your endoscopy. Most infections are minor and can be treated 
with antibiotics. Your doctor may give you preventive antibiotics before your 
procedure if you are at higher risk of infection. 
Tearing of the gastrointestinal tract. A tear in your esophagus or another part of your 
upper digestive tract may require hospitalization, and sometimes surgery to repair it. 
The risk of this complication is very low — it occurs in an estimated 3 to 5 of every 
10,000 diagnostic upper endoscopies. 
 
Other risks: 
You may also experience some brief and /or minor discomfort associated with 
the tests required.   
 
You may experience pain or bruising associated with the needle from the 
blood drawing.  Fainting and local infection can also occur when blood is 
drawn, although this is rare.  
 
You may feel pressure when the catheter is inserted into your urethra. 
 
While every reasonable effort will be made to ensure confidentiality of your 
protected and sensitive personal medical information, there is a risk this 
confidentiality could be compromised, although the study doctors to not 
expect this to occur.   
 
You may get tired or bored when we are asking you questions or you are 
completing questionnaires. You do not have to answer any question you do 
not want to answer. 
  
Future possibility of weight loss surgery will be limited after participating in 
this investigational study as the degree of risk of complications are no known 
and will need to be discussed with the surgeon. 
 
There may be side effects and discomforts that are not yet known.   
 
5. 
Are there benefits to being in the study? 
There may or may not be a direct benefit to you from being in this study. 
 

There is also a possibility that the information obtained in this study may help 
in the future development or improvement of treatment for patients who suffer 
from your condition.   
 
6. 
What are your options if you do not want to be in the study? 
 
 
If you decide not to join this study, other options are available.  You do not 
have to join this study to get treatment.  Other treatments include 
medications, surgery, and routine clinic visits.  
 
You do not have to join this study.  If you do not join, your care at will not be 
affected. 
 
7. 
Will it cost you anything to be in this study?   
You will receive a separate Insurance and Research Participant Financial 
Responsibility Information Sheet (Sheet).  
 
This Sheet will give you the following information: 
 
 The procedures, tests, drugs or devices that are part of this research 
and that will be paid for by the study (no cost to you).   
 
 
The procedures, tests, drugs or devices that will be billed to you and/or 
your health insurer.  If you have health insurance, you will be 
responsible for any co-pays or deductibles not covered by your 
insurance.  
 
8. 
Will you be paid if you join this study? 
No. 
 
9. 
Can you leave the study early? 
 You can agree to be in the study now and change your mind later. 
 If you wish to stop, please tell us right away. 
 Leaving this study early will not stop you from getting regular medical 
care.  
 If you leave the study early, researchers may use or give out your health 
information that it already has if the information is needed for this study or 
any follow-up activities. 
 
If you decide to participate in this study, it is expected that you will comply 
with the study requirements and periodic assessments.   
 
If you choose to withdraw from the study or if you are asked by your personal 
doctor to leave the study, you must notify your study doctor immediately.  If 

you withdraw from the study, the study sponsor will use the information 
collected up to the point you decide to withdraw. 
 
You will be informed of any new information that is learned while you are 
participating in this study that may affect your decision to continue your 
participation, and you may decide to withdraw at any time. 
 
If you withdraw or are removed from the study, for any reason, your study 
doctor will ask you to have a final evaluation.  This evaluation could include 
any of the assessments/tests previously mentioned in this document and any 
other procedures that the study doctor feels are medically necessary.  You 
may be asked questions about your experience with the study treatment.  You 
may also receive telephone calls to ask about the status of your disease.   
 
10. 
Why might we take you out of the study early?  
Your study doctor may also remove you from the study at any time based on 
the routine assessments.   You may be taken out of the study if: 
 Staying in the study would be harmful. 
 You need treatment not allowed in the study. 
 if it is decided that another approach could improve your medical care  
 You fail to follow instructions. 
 if you are not coming to study visits  
 The study is cancelled. 
 There may be other reasons to take you out of the study that we do not 
know at this time.  
If you are taken out of the study early, researchers may use or give out your 
health information that it already has if the information is needed for this study 
or any follow-up activities. 
 
If you choose to withdraw from the study or if you are asked by your personal 
doctor to leave the study, you must notify your study doctor immediately.  If 
you withdraw from the study, the study sponsor will use the information 
collected up to the point you decide to withdraw. 
 
If you withdraw or are removed from the study, for any reason, your study 
doctor will ask you to have a final evaluation.  This evaluation could include 
any of the assessments/tests previously mentioned in this document and any 
other procedures that the study doctor feels are medically necessary.  You 
may be asked questions about your experience with the study treatment.  You 
may also receive telephone calls to ask about the status of your disease.   
 
The study sponsor may discontinue the study at any time.  If the sponsor 
stops the study, your study doctor will arrange for appropriate treatment for 
you. 
 
 

11. 
How will your privacy be protected? 
Research institutions have  rules to protect information about you.  Federal 
and state laws also protect your privacy.   
 
The research team working on the study will collect information about you.  
This includes things learned from the procedures described in this consent 
form.  They may also collect other information including your name, address, 
date of birth, and other details. 
 
Generally, only people on the research team will know your identity and that 
you are in the research study.  However, sometimes other people at during 
your care may see or give out your information.  These include people who 
review research studies, their staff, lawyers, or other staff. 
 
People outside of this research institute may need to see your information for 
this study.  Examples include government groups (such as the Food and Drug 
Administration), safety monitors, other hospitals in the study and companies 
that sponsor the study. 
 
We cannot do this study without your permission to use and give out your 
information.  You do not have to give us this permission.  If you do not, then 
you may not join this study. 
 
We will use and disclose your information only as described in this form and 
in our Notice of Privacy Practices; however, people outside Johns Hopkins 
and Duke University and who receive your information may not be covered by 
this promise.  We try to make sure that everyone who needs to see your 
information keeps it confidential – but we cannot guarantee this. 
 
The use and disclosure of your information has no time limit. You may cancel 
your permission to use and disclose your information at any time by notifying 
the Principal Investigator of this study by phone or in writing.  If you contact 
the Principal Investigator by phone, you must follow-up with a written request 
that includes the study number and your contact information.  The Principal 
Investigator’s name, address, phones and fax information are on page one of 
this consent form.   
 
If you do cancel your permission to use and disclose your information, your 
part in this study will end and no further information about you will be 
collected. Your cancellation would not affect information already collected in 
the study. 
 
 
12. 
Will the study require any of your other health care providers 
to share your health information with the researchers of this 
study? 

As a part of this study, the researchers may ask to see your health care 
records or imaging from your other health care providers; however, these 
records will be anonymous and every reasonable effort will be made to 
remove information that may identify you with the record or imaging.  
 
 
13. 
What treatment costs will be paid if you are injured in this 
study?  
There is not a program to pay you if you are hurt or have other bad results 
from being in the study.  However, medical care ais open to you as it is to all 
sick or injured people.   
 
 If you have health insurance:  The costs for any treatment or hospital care 
you receive as the result of a study-related injury will be billed to your 
health insurer. Any costs that are not paid for by your health insurer will be 
billed to you.  
 
 If you do not have health insurance:  You will be billed for the costs of any 
treatment or hospital care you receive as the result of a study-related 
injury. 
 
 
By signing this form you will not give up any rights you have to seek 
compensation for injury.  
 
14. 
What other things should you know about this research 
study? 
a. What is the Institutional Review Board (IRB) and how does it protect 
you?  
The IRB is made up of: 
 Doctors 
 Nurses 
 Ethicists 
 Non-scientists 
 and people from the local community.  
 
The IRB reviews human research studies. It protects the rights and 
welfare of the people taking part in those studies.  You may contact the 
IRB if you have questions about your rights as a participant or if you think 
you have not been treated fairly.  The IRB office number is 410-955-3008. 
You may also call this number for other questions, concerns or complaints 
about the research.  
 
b. What do you do if you have questions about the study?    
Call the principal investigators, Dr. Arepally and Dr. Weiss, and their 
team at 410-502-2835. If you wish, you may contact the principal 

investigator by letter or by fax.  The address and fax number are on 
page one of this consent form. If you cannot reach the principal 
investigator or wish to talk to someone else, call the IRB office at 
410-955-3008.   
 
c. What should you do if you are injured or ill as a result of being in this 
study?  
If you think you are injured or ill because of this study, call the principal 
investigators, Dr. Arepally and Dr. Weiss , and their team at 410-502-2835 
during regular office hours.  
 
If you have an urgent medical problem related to your taking part in this 
study, call Dr. Weiss’s  team at 410-502-2835 during regular office hours 
and at 410-283-2835 after hours and on weekends. After the tone, enter 
the phone number where you can be called, press the # key, and hang up. 
 
d. What happens to Data, Tissue, Blood and Specimens that are 
collected in the study?  
Scientists work to find the causes and cures of disease. The data, tissue, 
blood and specimens collected from you during this study are important to 
both this study and to future research. 
 
If you join this study: 
 You will not own the data, or the tissue, blood, or other specimens 
given by you to the investigators for this research. 
 Researchers of this research may study your data and the tissue, 
blood or other specimens collected from you. 
 If data, tissue, blood, or other specimens are in a form that identifies 
you, researchers may use them for future research only with your 
consent or IRB approval. 
 If data, tissue, blood or other specimens are in a form that we believe 
does not identify you, they may be shared with other academic medical 
centers, non-profit organizations, corporate sponsors and other 
commercial companies without your consent or IRB approval.  
 You will not own any product or idea created by the researchers 
working on this study. 
 You will not receive any financial benefit from the creation, use or sale 
of such a product or idea. 
 
 
 
 
 
15. 
What does your signature on this consent form mean? 
 
Your signature on this form means that: 

 you understand the information given to you in this form  
 you accept the provisions in the form 
 you agree to join the study  
 
You will not give up any legal rights by signing this consent form.  
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED 
CONSENT FORM 
 
_____________________________________________________________________________________________________
_____________________ 
Signature of Participant                                                                                                                                      
Date/Time  
 
_________________________________________________________________________
________________ 
Signature of Person Obtaining Consent                                                                                                             
Date/Time 
 
_________________________________________________________________________
_________________ 
Signature of Witness to Consent Procedures (optional unless IRB or Sponsor required)                                
 
 Date/Time 
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE 
PRINCIPAL INVESTIGATOR; A COPY MUST BE GIVEN TO THE PARTICIPANT; AND, 
IF APPROPRIATE A COPY OF THE CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S MEDICAL RECORD.