Bariatric Embolization of Arteries With Imaging Visible Embolics
Phase: NA
Conditions: Obesity, Morbid Obesity, Weight Loss
Sponsor: Johns Hopkins University

Bariatric Embolization of ArTeries with imaging visibLe EmbolicS 
(BEATLES) 
Protocol Number: BAE2 
National Clinical Trial (NCT) Identified Number:  04197336 
Principal Investigator: Clifford Weiss, MD 
IDE Sponsor: Clifford Weiss, MD 
Funded by:  
Biocompatibles UK Ltd (internal study number BTG-001933-01)  
and Siemens Healthcare 
Version Number:  v4  
7 October 2020 
 
 
Summary of Changes from Previous Version: 
Affected Section(s) 
Summary of Revisions Made 
Rationale 
Table of Contents 
Taste Test has been removed 
 
1.3 
SOA:   
• 
Taste test (deleted) 
• 
Gastric Meds (added) 
• 
Pain Prophylaxis (added) 
 
 
2.3 
Pain Management: IV acetaminophen (added) 
 
4.1 
Overall Design: 5 run-in participants (removed) 
10 pilot patients (added) 
 
5.2 
Exclusion Criteria Addition:  Use of anti-obesity 
medications in the 12 months prior to screening 
 

NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template   
ii 
 
5.5  
Payment table revised: removal of the taste test 
 
6.3 
Measures to Minimize Bias: Site Training 
Randomization and Blinding: 
5 run-in patients (removed) 
10 pilot patients (added) 
 
8.2.12 
Removal Taste Test Description 
 
8.2.19 
Removal of Taste Test associated questionnaires 
 
9.3 
Populations for Analyses: 
5 run-in (removed) 
Ten pilot (added) 
 
9.4.6 
Planned Interim Analyses: 
5 run in patients (removed) 
Ten (10) pilot patients (added) 
 
10.1.6  
Safety Oversight:  
first 5 (non-randomized) (removed) 
first 10 (non-randomized) pilot participants (added) 
 

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Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................................................... 4 
1 
PROTOCOL SUMMARY ................................................................................................................................... 4 
1.1 
Synopsis .................................................................................................................................... 4 
1.2 
Schema ..................................................................................................................................... 6 
1.3 
Schedule of Activities (SoA) ......................................................................................................... 7 
2 
INTRODUCTION ............................................................................................................................................... 8 
2.1 
Study Rationale .......................................................................................................................... 8 
2.2 
Background ................................................................................................................................ 8 
2.2.1 STOMACH IS AN ENDOCRINE ORGAN ..................................................................................................... 8 
2.2.2 ANATOMY OF THE GASTRIC FUNDUS ...................................................................................................... 8 
2.2.3 gHRELIN SUPPRESSED AFTER GASTRIC BYPASS SURGERY .............................................................. 9 
2.2.4 ABSTRACT…….…..………………………………………………………………………………………………….9 
2.3 
Risk/Benefit Assessment ........................................................................................................... 10 
2.3.1 
Known Potential Risks ………………………………………………………………………………………….10 
2.3.2 
Known Potential Benefits ...................................................................................................................... 14 
2.3.3 
Assessment of Potential Risks and Benefits ......................................................................................... 14 
3 
OBJECTIVES AND ENDPOINTS .................................................................................................................... 14 
4 
STUDY DESIGN .............................................................................................................................................. 16 
4.1 
Overall Design .......................................................................................................................... 16 
4.2 
Scientific Rationale for Study Design .......................................................................................... 16 
4.3 
Justification for Dose ................................................................................................................. 16 
4.4 
End of Study Definition .............................................................................................................. 17 
5 
STUDY POPULATION .................................................................................................................................... 17 
5.1 
Inclusion Criteria ....................................................................................................................... 17 
5.2 
Exclusion Criteria ...................................................................................................................... 17 
5.3 
Lifestyle Considerations ............................................................................................................. 19 
5.4 
Screen Failures ........................................................................................................................ 19 
5.5 
Strategies for Recruitment and Retention .................................................................................... 20 
6 
STUDY INTERVENTION ................................................................................................................................. 21 
6.1 
Study Intervention(s) Administration ............................................................................................ 21 
6.1.1 
Study Intervention Description .............................................................................................................. 21 
6.2 
Preparation/Handling/Storage/Accountability ............................................................................... 22 
6.2.1 
Acquisition and accountability ............................................................................................................... 22 
6.2.2 
Formulation, Appearance, Packaging, and Labeling............................................................................. 22 
6.2.3 
Product Storage and Stability ............................................................................................................... 23 
6.2.4 
Preparation………………………………………………………………………………………………………23 
6.3 
Measures to Minimize Bias: SIte Training Randomization and Blinding .......................................... 24 
6.4 
Study Intervention Compliance ................................................................................................... 24 
6.5 
Concomitant Therapy ................................................................................................................ 24 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL .. 25 
7.1 
Discontinuation of Study Intervention .......................................................................................... 25 
7.2 
Participant Discontinuation/Withdrawal from the Study ................................................................. 26 
7.3 
Lost to Follow-Up ...................................................................................................................... 26 
8 
STUDY ASSESSMENTS AND PROCEDURES .............................................................................................. 27 
8.1 
Study Period definitions ............................................................................................................. 27 
8.2 
Study assessments and Procedures definitions ........................................................................... 28 
8.2.1 Informed Consent….……………………………….………………………………………………………………..28 
8.2.2 Demographics………………………………………………………………………………………………………..28 
8.2.3 History & Physical.…………………………………………………………………………………………………..28 
8.2.4 Psychological Evaluation….………………………………………………………………………………………..29 

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8.2.5 Blood, Urine, and Stool Tests.……………………………………………………………………………………..29 
8.2.6 Pregnancy Test.……………………………………………………………………………………………………..30 
8.2.7 3D CTA……………………………………………………………………………………………………………….30 
8.2.8 Gastric Emptying..……..…………………………………………………………………………………………….30 
8.2.9 Endoscopy with Biopsy..………...………………………………………………………………………………….30 
8.2.10 Quality of Life Questionnaires ................................................................................................................... 30 
8.2.11 Hormone Tests……………………………………………………………………………………………………..31 
8.2.13 MRI (with AMRA Profiler) ………………………………………………………………………………………….31 
8.2.14 Weight Management Counseling .............................................................................................................. 31 
8.2.15 Randomization….…………………………………………………………………………………………………..31 
8.2.16 Bariatric Embolization/Sham Procedure .................................................................................................... 32 
8.2.17 CBCT………………….…………………………………………………….……………………………………….32 
8.2.18 Assessment of AEs….………………………………………………………………………………………….….32 
8.2.19 Food Logs………………………………………………………….………………………………………………..32 
8.2.20 Hunger Satiety Scale..……………………………………………………………………………………………..32 
   8.2.21 HealthReel…………………..…………………..…………………..…………………..……………………….…33   
8.3 
Adverse Events and Serious Adverse Events ....................................................................................... 32 
8.3.1 
Definition of Serious Adverse Events (SAE) and Serious Adverse device effects (SADE) …………....33 
8.3.2 
Classification of an Adverse Event........................................................................................................ 33 
8.3.3 
Time Period and Frequency for Event Assessment and Follow-Up ...................................................... 34 
8.3.4 
Adverse effect Reporting ...................................................................................................................... 35 
8.3.5 
Serious Adverse Effect Reporting ......................................................................................................... 35 
8.3.6 
Reporting Events to Participants ........................................................................................................... 36 
8.3.7 
reporting of Adverse events to the manufacturer .................................................................................. 36 
8.3.8 
Reporting of Pregnancy ........................................................................................................................ 36 
8.4 
Unanticipated Problems ............................................................................................................. 36 
8.4.1 
Definition of Unanticipated Problems (UP) ............................................................................................ 36 
8.4.2 
Unanticipated Problem Reporting ......................................................................................................... 36 
9 
STATISTICAL CONSIDERATIONS ................................................................................................................. 37 
9.1 
Statistical Hypotheses ............................................................................................................... 37 
9.2 
Sample Size Determination ........................................................................................................ 37 
9.3 
Populations for Analyses ........................................................................................................... 38 
9.4 
Statistical Analyses ................................................................................................................... 38 
9.4.1 
General Approach..……………………………………………………………………………………………..38 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ........................................................................................ 39 
9.4.3 
Analysis of the Secondary Endpoint(s) ................................................................................................. 39 
9.4.4 
Safety Analyses..………………………………………………………………………………………………..39 
9.4.5 
Baseline Descriptive Statistics .............................................................................................................. 40 
9.4.6 
Planned Interim Analyses ..................................................................................................................... 40 
9.4.7 
Sub-Group Analyses ………………………………………………………………………………………….40 
9.4.8 
Tabulation of Individual participant Data ............................................................................................... 40 
9.4.9 
Exploratory Analyses ………………………………………………………………………………………….40 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................................ 40 
10.1 
Regulatory, Ethical, and Study Oversight Considerations .............................................................. 40 
10.1.1 
Informed Consent Process ................................................................................................................... 40 
10.1.2 
Study Discontinuation and Closure ....................................................................................................... 41 
10.1.3 
Confidentiality and Privacy .................................................................................................................... 41 
10.1.4 
Future Use of Stored Specimens and Data .......................................................................................... 42 
10.1.5 
Key Roles and Study Governance ........................................................................................................ 42 
10.1.6 
Safety Oversight….……………………………………………………………………………………………..43 
10.1.7 
Clinical Monitoring…..…………………………………………………………………………………………..43 
10.1.8 
Quality Assurance and Quality Control ................................................................................................. 44 
10.1.9 
Data Handling and Record Keeping ...................................................................................................... 44 
10.1.10 Protocol Deviations..…………………………………………………………………………………………....45 

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10.1.11 Publication and Data Sharing Policy ..................................................................................................... 45 
10.1.12 Conflict of Interest Policy ...................................................................................................................... 45 
10.2 
Additional Considerations .......................................................................................................... 45 
10.3 
Abbreviations ........................................................................................................................... 46 
10.4 
Protocol Amendment History ...................................................................................................... 47 
11 
REFERENCES ................................................................................................................................................ 48 
 
Appendix A: Post Procedure Diet Plan (1 Week) ……………………………………….……………………………………52 
 
 
STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations 
(CFR). The Principal Investigator, who in this case is also the Investigational Device Exemption 
(IDE) sponsor, will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from or notification of the funding agency and documented approval 
from the FDA and Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study 
have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval.  Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study.  All 
changes to the consent form will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
1 
 
PROTOCOL SUMMARY 
1.1 SYNOPSIS  
Title: 
Bariatric Embolization of ArTeries with imaging visibLe EmbolicS 
(BEATLES) 
Study Description: 
The BEATLES study is an investigator-initiated, prospective, double-
blinded, randomized, sham-controlled study that will assess the 
impact of bariatric embolization on the systemic levels of obesity-
related hormones and, as a consequence, on weight loss. The goal 
of this study is to help treat obesity combining a lifestyle program 
and a minimally invasive, angiographic (i.e., through blood vessels) 
approach. 
Objectives: 
 
Primary Objective:  To determine the efficacy of the BAE procedure 
using radiopaque 100-200 μm microspheres (BTG-001933) for 
weight loss in obese patients. 
 
Secondary Objectives: To determine the safety and further explore 
the efficacy of the BAE procedure using radiopaque 100-200 μm 
microspheres (BTG-001933) for weight loss in obese patients  
Endpoints: 
Primary Endpoint: Change in body weight 12 months after 
randomization 
Primary Safety Endpoints: All adverse events until the end of the 
study (12 months) 

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Secondary Endpoints:  
1) All adverse events until day 30 post embolization 
2) Change in body weight at timepoints other than 12 months 
3) Percentage change in body weight 
4) Achievement of >5% reduction in body weight 
5) Percentage excess weight loss (EWL) 
6) Change in multi-compartment body fat composition as measured 
by MRI 
Study Population: 
59 adult men and women, ages 21-70 years, with a body mass index 
(BMI) ≥35 kg/m2 and otherwise suitable for protocol therapy at the 
Johns Hopkins Hospital  
Phase: 
2 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
1 site: Johns Hopkins Hospital 
Description of Study 
Intervention: 
Minimally invasive, non-surgical, angiographic bariatric embolization 
(BAE) of the left gastric and/or gastroepiploic arteries using 
investigational 100-200 µm radiopaque microspheres (BTG-001933, 
Biocompatibles UK, Ltd) 
Study Duration: 
3 years 
Participant Duration: 
12 months 
 
 

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1.2 SCHEMA 
 
 

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1.3 SCHEDULE OF ACTIVITIES (SOA) 
 
Procedure 
Pre-
Procedure 
Procedure 
Day 
Follow-Up 
1 
week 
(±1 
day) 
2 
weeks 
(±3 
days) 
4 
weeks 
(±3 
days) 
3 
months 
(±14 
days) 
6 
months 
(±14 
days) 
12 
months 
(±14 
days) 
Informed Consent  
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
History & Physical 
X 
X 
X 
X 
X 
 
 
 
Study Team Visitβ 
X 
 
X 
X 
X 
X 
X 
X 
Psychological Evaluation∆ 
X 
 
 
 
X 
X 
X 
X 
Blood & Urine Tests 
X 
X*** 
X 
X 
X 
X 
X 
X 
Pregnancy Test* 
X 
X*** 
 
 
 
X 
X* 
X* 
Stool Occult Blood Study 
X 
 
 
 
 
 
 
 
3D CTA 
X 
 
 
 
 
 
 
 
Gastric Emptying* 
X 
 
 
 
 
X 
X 
 
Endoscopy with biopsy 
X 
 
 
 
 
X◊ 
X* 
X* 
Quality of Life 
Questionnaires 
X 
 
X 
X 
X 
X 
X 
X 
Hormone Tests 
X 
 
X 
X 
X 
X 
X 
X 
MRI 
X 
 
 
 
 
X 
X 
X 
Weight Management 
Counseling (Johns 
Hopkins Healthful 
Eating, Activity & Weight 
Program) †  
8 visits over 2 
monthsα 
 
 Months 1-2: MD/WC alternating weekly, starting w/ WC; 
Months 3-5: MD 2x/mo; Month 6: MD 1x/mo, WC 1x/mo; 
Month 7-12: MD 1x/mo 
Randomization 
 
X 
 
 
 
 
 
 
Gastric Meds 
X 
X 
6 weeks post procedure 
 
 
Bariatric Embolization**/ 
Sham Procedure 
 
X 
 
 
 
 
 
 
CT/CBCT 
 
X 
 
 
 
 
 
 
Pain Prophylaxis 
 
X 
AM 
post 
BAE 
only 
 
 
 
 
 
Assessment of AEs 
 
X 
X 
X 
X 
X 
X 
X 
Lose It! Food Log 
Start 7 days 
prior to first 
WM visit 
 
Subject completes food log on Lose It! application daily, 
reviewed at each provider WM visit 
ASA 24 
X 
 
 
X 
X 
X 
X 
X 
Hunger Satiety Scale 
X 
 
 
 
X 
X 
X 
X 
HealthReel  
X 
 
 
 
 
X 
X 
X 
Unblinding Survey 
 
 
 
 
X 
 
 
X 
*If applicable, e.g. in diabetic patients only (gastric emptying), female of child-bearing ability (pregnancy tests at baseline and 3 
months), in case of symptoms (endoscopy in months 6 and 12), in case of endoscopy (pregnancy tests in months 6 and 12) 
**Participants will be admitted to the hospital after the embolization or sham procedure.  
***These labs will be performed if previous test results are >30 days old. 
†Weight management schedule: weekly visits with the Johns Hopkins Healthful Eating, Activity & Weight Program during 8-week 
run-in and first 8 weeks post-procedure, consisting of either a visit with a physician or a weight check with a nurse. (MD: physician 
visit, WC: weight check)  
αWeekly visits with the  Johns Hopkins Healthful Eating, Activity & Weight Program ,with the following schedule: week 1: intake with 
provider (1 hour); weeks 2-3: weight check (15 minutes); week 4: provider follow-up visit (15 minutes); weeks 5-6: weight check (15 
minutes); weeks 7-8: provider follow-up visit (15 minutes)  

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βStudy team visits will consist of a meeting with one of the interventional radiology fellows or study physicians as well as the study 
coordinators in order to check in with the patient regarding how they are doing. The post-procedural study team visits at 2- and 4-
weeks post-procedure will include a physical exam. 
∆Psychology visits may be completed remotely (i.e. telehealth) if clinically indicated—this will be at the discretion of the study 
psychologists.Follow-up visits may be conducted more frequently than specified (i.e. optional 9-month visit).  
2 
 
INTRODUCTION 
 
2.1 STUDY RATIONALE  
 
The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, 
sham-controlled study that will assess the impact of bariatric embolization of the left gastric 
artery and/or gastroepiploic arteries on the systemic hormonal levels of obesity and weight loss. 
The goal of this study is to help treat obesity using a minimally invasive, non-surgical, 
angiographic (i.e., through blood vessels) approach. This Investigational Device Exemption 
(IDE) is requested to support the use of 100 – 200µm BTG-001933 microspheres in bariatric 
artery embolization for the treatment of obesity. The BTG-001933 microsphere (Biocompatibles 
UK, LTD) is an investigational device based on the legally marketed LC Bead LUMITM (K152157, 
K162373), which has an approved indication for use of embolization of hypervascular tumors 
and arteriovenous malformations. The BTG-001933 microsphere is the result of modification of 
the LC Bead LUMITM with respect to bead size range and iodine content. These device 
modifications may facilitate and optimize imaging techniques associated with the planned 
procedure. 
 
2.2 BACKGROUND  
 
2.2.1 STOMACH IS AN ENDOCRINE ORGAN 
 
Although there are >40 hormones that limit food intake, there is only one hormone, ghrelin, that 
has been shown to be orexigenic, i.e., stimulate food intake. Discovered by Kojma et al. in the 
rat stomach, it has been 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 in human volunteers, intravenous ghrelin stimulates meal 
initiation, with nearly half of volunteers describing a sensation of hunger and a compensatory 
increase of 28% in caloric intake.(4) Further evaluation has shown that in humans, there is a 
consistent pattern of ghrelin levels rising shortly before, and falling 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 the lower body weight.(5) In many but not all 
obese participants, food fails to suppress systemic ghrelin levels, which can impair postprandial 
satiety and initiate overeating.(6) Due to the potent orexigenic effect of ghrelin, this hormone is a 
target for the treatment of obesity and weight loss. However, although various reports of ghrelin 
suppression have been described, none are clinically practical. 
 
2.2.2 ANATOMY OF THE GASTRIC FUNDUS 
 
The stomach is classically separated into seven major sections: cardia, fundus, antrum, pylorus, 
lesser curvature, greater curvature, and angularis (Figure 1A). While each section of the 

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stomach has a unique role in the 
digestive process, the fundus serves 
as the epicenter for the 
neuroregulatory pathway involved in 
satiety and appetite stimulation.(7-10) 
Ghrelin is expressed mainly in the 
fundus, which contains 10 to 20 times 
more ghrelin per gram of tissue than 
the duodenum, the next richest 
source, and has a higher level of 
growth hormone secretagogue (GHS) 
receptor activation than the 
hypothalamus.(11, 12) Notably, the 
vascular supply to the gastric fundus is distinct, identifiable, and can be accessed with a 
catheter using 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).  
 
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 gastrointestinal (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 participants whose condition is refractory to endoscopic 
control of gastrointestinal bleeding. 
 
2.2.3 GHRELIN SUPPRESSED AFTER GASTRIC BYPASS SURGERY 
 
More recently, ghrelin has been found to have a significant role in the long-term effect of weight 
loss following bariatric surgery. Since bariatric surgery isolates the gastric fundus from ingested 
nutrients, ghrelin profiles are shown to be lower by 77% compared to those in controls.(7,13-15) 
Furthermore, the normal diurnal pattern of ghrelin is interrupted, and the meal-initiated 
fluctuations are blunted.(7,13) Based on these findings, achieving low systemic ghrelin levels 
should be considered as a strategy to control obesity and maintain weight loss. 
 
2.2.4 OVERVIEW OF BEATLES  
 
Obesity is defined as a body mass index (BMI) ≥30 kg/m2 and with a subclass of obesity known 
as morbid or severe obesity (BMI of ≥40 kg/m2). These are major issues in medicine for both 
participants and medical providers with >36% of the US population affected. Obesity is one of 
the biggest causes of preventable chronic diseases and healthcare costs in the USA. Obese 
adults spend 42% more on direct healthcare costs and morbidly obese adults overall have 81% 
higher healthcare costs than non-obese adults. Obesity is currently treated with dietary, 
pharmacological, and/or surgical approaches that are often unsuccessful or are associated with 
additional risks. As the incidence and prevalence of obesity and obesity-related diseases are 
steadily increasing, there is a growing need to detect the key risk factors involved in disease 
development and modify standard treatment procedures and protocols.  
 
The most successful long-term strategy continues to be bariatric and metabolic surgeries, such 
as sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP). The NIH recommends bariatric 

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surgery for participants with a BMI of 40 kg/m2 or greater or a BMI of 35 kg/m2 or greater and 
obesity related comorbidities. These surgeries enable participants to lose between 50% and 
75% of excess body weight. Despite this success, participants are apprehensive and do not 
undergo bariatric surgery with the biggest fear being the many complications that come with the 
procedure. Studies have shown that 57-77% of participants are not interested in bariatric 
surgery although they qualify.(16) 
 
With the concern of complications from bariatric surgery, interest in endoscopic bariatric 
techniques has increased over the years. They have been shown to be efficacious, reversible, 
relatively safe, and cost effective. Further, these techniques offer a therapeutic window for some 
participants who may otherwise be unable to undergo bariatric surgery. The American Society 
for Gastrointestinal Endoscopy have approved endoscopic procedures, such as balloon therapy, 
for participants with BMI in the 30-40 kg/m2 range.(17,18)  However, the products used in these 
therapies also have several limitations primarily the inability to provide long term weight loss 
given the temporary nature of these balloons.(19) Common adverse events following 
intragastric balloon insertion include abdominal pain (33.7%), gastroesophageal reflux disease 
(18.3%), anorexia, and nausea (29%). Severe complications such as gastric ulcers (2%), small 
bowel obstruction (0.3%), perforation (0.1%), balloon migration (1.4%), and death (0.08%) are 
less common. Early balloon removal occurred in 9.1% of the study participants due to 
participant intolerance.(20)    
 
In a pilot study to assess safety and efficacy (BEAT Obesity), 20 morbidly obese participants 
with a BMI of ≥40 kg/m2 with no other comorbid conditions underwent bariatric embolization and 
were followed for 12 months. Participants were embolized with 300-500 µm Embospheres. 
None of the 20 participants in the BEAT Obesity trial (the largest prospective trial to date) had 
any major adverse events. Any gastric ulcers that occurred (40%) were asymptomatic and were 
completely healed by three months after the procedure.(21) 
 
There were many limitations of this study including the absence of a control cohort and non-
compliance amongst study participants. A target population of participants with a BMI of 40 
kg/m2 and above was too high considering the bariatric embolization procedure is comparable to 
endoscopic bariatric therapies rather than bariatric surgery. BEAT Obesity excluded participants 
with comorbidities, such as those who suffer from diabetes, who may greatly benefit from this 
procedure and are often the target population for endoscopic/surgical bariatric therapies.  A 
larger bead size of 300-500 µm was specifically chosen compared to preclinical data and prior 
clinical reports due to concerns of gastric ischemia and ulceration. However, smaller bead size 
produces greater weight loss and hormonal shifts.(22)  
 
We hypothesize that transvascular bariatric embolization results in safe and effective weight 
loss in obese participants compared to control subjects.  
 
2.3 RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
The prior BEAT Obesity clinical trial allowed for identification of three major areas of risk for 
bariatric embolization: Gastric Ulcers, Increased Radiation Dose in Obese Participants, and Non 
Target Vascular Embolization (NTE). 
 

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Gastric Ulcers 
 
As was done in the BEAT Obesity Trial, all participants will be treated with gastroprotective 
agents to mitigate the risks for gastric ulcers. In addition, all participants will be heavily screened 
to identify and exclude all participants who would be at higher risk for gastric ulcerations.  
 
Currently, arterial embolization with 100-300 µm particles is routinely clinically performed for a 
number of indications (including embolization of the gastric fundus for control of hemorrhage), 
and has not been shown to have significant clinical sequelae of tissue necrosis or infarction. In 
fact, all the investigators in the BEATLES trial have embolized the gastric fundus for 
gastrointestinal hemorrhages with particles, and have not seen any cases of gastric 
ulceration/perforation. In the prior BEAT Obesity trial, the procedure was carried out safely with 
a 300-500 µm embolic, and 8/20 participants had superficial gastric mucosal ulceration seen at 
2 weeks, all of which were healed at 3 months. In all reported studies world-wide published at 
this time, transient superficial mucosal ulcers were commonly observed and none were deemed 
major complications or major adverse events. 
 
Radiation Dose 
 
The mean radiation dose in the prior BEAT Obesity trial was 5042.6 (±996) mGy, well below 
NRC reporting thresholds. There were no radiation associated injuries in any participants 
observed at follow-up clinic visits. The BEATLES study will use an in-procedure CT scan to 
serve the same purpose as did the cone beam computed tomography (CBCT) did in the BEAT 
Obesity Trial, to minimize the risk of NTE and to determine fundal perfusion. The modified 
fluoroscopic time and software algorithms to reduce radiation exposure developed in the BEAT 
Obesity Trial will be used in the BEATLES study.  
 
Non Target Vascular Embolization (NTE) 
 
Due to the proximity of the dorsal pancreatic artery to the left gastric artery, and the pancreatico-
duodenal arcade to the gastroepiploic artery, it is possible that the risk of pancreatitis is still 
relevant. In the BEAT Obesity trial, one participant had post-procedural elevation in pancreatic 
enzymes, which might have been attributable to reflux/NTE during distal gastroepiploic arterial 
embolization. To minimize such reflux and NTE, the spheres are now routinely diluted in a larger 
volume of contrast/saline to prevent proximal clumping, which can cause reflux. Also, 3D CTA 
prior to the procedure and CBCT were used in all five participants to further map the vascular 
anatomy. However, due to technical/anatomical challenges, an anti-reflux system was used in 
one vessel. Moving forward, the use of preventative measures may still be employed to mitigate 
NTE. Of course, the use of an imaging-visible embolic will be essential to determine the location 
of embolic delivery, and to fully assess any NTE.   
 
There are certain risks and discomforts that may be associated with this research study. 
Previous studies have shown the following side effects: 
• 
Some participants had mild abdominal discomfort after the procedure, lasting less than 
two weeks. 
• 
In initial clinical experiments, around 40% of participants had mild gastric irritation with 
minor ulceration assessed by endoscopy, which had healed by the time of the repeat 
examination at three months.   

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• 
20% of participants reported mild to moderate constipation for up to three months after 
the procedure.   
• 
In addition, mild delays in gastric emptying occurred in 1/20 participants with resolution 
at six months. This might result in nausea, vomiting, and/or abdominal pain. 
• 
Side effects may result from particles lodging into areas outside the targeted stomach 
area (NTE), resulting in blockage of the blood vessels to the bowel, liver, gallbladder, 
pancreas, spleen, groin, bladder, pelvis, or legs. If severe, they may need to be 
corrected by surgery.   
• 
Other possible events include nausea, vomiting, inflammation of the stomach, ulceration, 
bleeding from the stomach, stomach rupture or death. Bleeding from the area in the 
thigh or wrist where the catheter is inserted, allergic reaction to the contrast agent, an 
effect on fertility, damage (perforation) to a blood vessel that can lead to hemorrhage, a 
temporary contraction in a blood vessel (vasospasm), or bruise in the groin or wrist area 
(hematoma) are also possible. 
• 
Blood clots in the veins (deep vein thrombosis) or lungs (pulmonary embolism) or death 
are unlikely.   
 
It is possible that there will be other short-term or long-term complications, including the inability 
to have future gastric surgery. Patients will be educated that, at a minimum, a gastric angiogram 
is recommended prior to any future gastric surgery.  
 
Risks from Gastro-protective Medications 
 
Omeprazole is a proton pump inhibitor that works by decreasing the amount of acid produced 
by the stomach and is typically used to treat certain conditions including, but not limited to, 
gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). 
Sometimes, omeprazole is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) 
to treat ulcers associated with infection caused by the H. pylori bacteria. Omeprazole is also 
used to treat dyspepsia, a condition that causes sour stomach, belching, heart burn, or 
indigestion.  
 
The most frequent significant adverse effects occurring in at least 1% of participants in the 
BEAT Obesity Trial taking omeprazole included: 
• 
Central nervous system: headache (7%), dizziness (2%) 
• 
Respiratory: upper respiratory infection (2%), cough (1%) 
• 
Gastrointestinal: abdominal pain (5%), diarrhea (4%), nausea (4%), vomiting (3%), 
flatulence (3%), acid regurgitation (2%), constipation (2%) 
• 
Neuromuscular & skeletal: back pain (1%), weakness (1%) 
• 
Dermatologic: rash (2%) 
 
There are other very rare, potential concerns of taking omeprazole related to adverse effects: 
• 
Bacteria-associated diarrhea 
• 
Increased risk of pneumonia 
• 
Osteoporosis-related fractures 
• 
Hypomagnesemia 
• 
There is concern regarding vitamin B12 and iron malabsorption, but the effects seem to 
be clinically insignificant, especially when supplemental therapy is provided.    
 

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Sucralfate is used to treat and prevent duodenal ulcers, as well as other conditions as 
determined by a doctor. Sucralfate works by forming a “barrier” or “coating” over the ulcer, 
protecting the ulcer from stomach acid and allowing it to heal. Sucralfate contains an aluminum 
salt. The most common side effects seen are constipation (2-3%) and bezoar formation. Less 
commonly reported effects include flatulence, headache, hypophosphatemia, and dry mouth. 
 
Omeprazole and sucralfate will be prescribed to every participant. Antibiotics will only be 
prescribed to treat an accompanying infection.  
 
Pain Management 
IV acetaminophen (or a similar pain management medication) will given prophylactically for pain 
during and after the procedure.  Dosage of IV acetaminophen will follow standard of care 
guidelines for use and will be paid for by the study.  The most common adverse event 
associated with IV acetaminophen are nausea, vomiting, headache, and insomnia. 
 
 
 
 
CT Angiography 
 
Allergy to the contrast agent or injury from radiation exposure during imaging are possible. If a 
participant has an allergic reaction to the contrast agent, he/she will not be allowed to continue 
with the embolization procedure. 
 
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 the participants’ medical care. X-rays and gamma rays can damage the 
genetic material (DNA) in cells. At low doses, cells usually can repair this damage.  
 
The radiation exposure that participants will receive is an average of 4.2 rem, depending on the 
participants’ diabetic status, weight, and procedural difficulty. This exposure is more than the 0.3 
rem that the average person in the US gets each year from natural sources like the sun, outer 
space, air, food, and soil. Most participants will receive less than the 5 rem of radiation that is 
allowed each year for people who are exposed to radiation in their jobs.  
 
The radiation exposure described here is what participants will get from this research study 
only. It does not include any exposure the participants may have received or will receive from 
other tests outside of this study that are a part of their medical care. Radiation risk builds up with 
each exposure. Participants should think about their own history of radiation exposure from 
tests (like x-rays or CT scans) when deciding about the radiation in this study.  
 
Endoscopy with biopsy 
 
Upper endoscopy is a very safe procedure. However, it carries a very small risk of 
complications. Rare complications include: 
• 
Bleeding. Risk of bleeding complications after endoscopy is increased because 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.  

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• 
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 the endoscopy. Most infections are minor and can be treated with antibiotics. Primary 
physicians may give participants preventive antibiotics before their procedure if they are 
at higher risk of infection. 
• 
Tearing of the GI tract. A tear in the esophagus or another part of the 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 three to five of every 10,000 
diagnostic upper endoscopies. 
 
Other Risks 
 
Participants may also experience some brief and/or minor discomfort associated with the tests 
required.   
• 
Taking blood may cause discomfort, bleeding, or bruising where the needle enters the 
body. In rare cases, it may result in fainting. There is a small risk of infection. 
• 
While every reasonable effort will be made to ensure confidentiality of protected and 
sensitive personal medical information, there is a risk that this confidentiality is 
compromised, although the study doctors to not expect this to occur.   
• 
Participants may get tired or bored when asked questions or when completing 
questionnaires. Participants do not have to answer any question they do not want to 
answer. 
• 
Future possibility of weight loss surgery may be limited after participating in this 
investigational study, as the degree of risk of complications are not known and will need 
to be discussed with the surgeon. 
• 
Risks of MRI may include patients being bothered by the noise and experiencing 
claustrophobia. 
• 
There may be side effects and discomforts that are not yet known.   
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
There is no guarantee of specific benefit to the participants enrolled in this study, however all 
participants will receive free weight management care from the Johns Hopkins Hospital 
comprehensive weight management center and free psychological counseling through the 
study. Data collected in this clinical investigation will provide a foundation for future efficacy 
studies and analyses. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
The trial is being done to determine the efficacy and safety of the BAE procedure using the 
modified microsphere. All identified risks will be mitigated as described above. Active 
surveillance by the DSMB of known risks as outlined and with respect to complications listed in 
the IFU will occur with mitigation or stopping plans in place should any of the known risks 
exceed expected thresholds. It is concluded that the value of the information to be gained 
outweighs the risks of participation in the study based on the prior experience of the 
investigators and the anticipated low frequency of expected events.  
 
3 
OBJECTIVES AND ENDPOINTS 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
To determine the efficacy of the 
BAE procedure using radiopaque 
100-200 μm microspheres (BTG-
001933) for weight loss in obese 
patients  
 
Primary Safety: To determine the 
safety of the BAE procedure using 
radiopaque 100-200 μm 
microspheres (BTG-001933) for 
weight loss in obese patients 
 
Change in body weight 12 months 
after randomization 
 
 
 
 
Frequency of AEs 12 months after 
randomization 
This is the standard for weight 
management trials. 
 
 
 
 
Safety determination is required for 
investigation of this non-FDA 
approved device. 
Secondary 
 
 
To determine the safety and further 
explore efficacy of the BAE 
procedure using radiopaque 100-
200 μm microspheres (BTG-
001933) for weight loss in obese 
patients  
 
1) 
All adverse events (AEs) until 
30 days post embolization  
2) 
Change in body weight at 
timepoints other than 12 
months 
3) 
Percentage change in body 
weight 
4) 
Achievement of >5% reduction 
in body weight 
5) 
Changes in multi-compartment 
body fat composition as 
measured by MRI 
1: Safety determination is required 
for investigation of this non-FDA 
approved device.  
 
2: Weight measurements are 
standard for weight management 
trials. 
 
3 & 4: These endpoints are often 
used in phase 3 weight 
management trials and will allow for 
comparison to FDA-approved 
obesity treatments. 
 
5: MRI is a new measure of BMI 
and will be done specifically to 
measure and compare detailed 
compartmental weight changes 
between the intervention and 
control groups. This endpoint will 
also provide insight into patient 
selection for future trials. 
Tertiary/Exploratory  
 
 
To explain and support findings of 
the primary analyses and for 
suggesting further hypotheses for 
later research. 
1) 
Change in blood pressure 
2) 
Lipid/lipoprotein profile  
3) 
Change in obesity-related 
hormones 
a. 
Ghrelin, LEAP2, 
leptin, glucagon-like 
peptide-1 (GLP-1), 
peptide YY (PYY) etc. 
4) 
Improvement in markers of 
obesity-related complications 
(glycaemia as assessed by 
HbA1c, fasting glucose and 
insulin, change in medication 
effect score (MES)) 
5) 
Food intake 
6) 
Hunger/satiety assessments 
7) 
Quality of life parameters 
survey: IWQOL-Lite             
8) 
Results from endoscopy 
1-4, 9: Laboratory and blood 
pressure data will permit measures 
of cardiovascular and metabolic 
health. In addition, the obesity-
related hormones believed to be the 
underlying mechanism of BAE 
success, will be monitored over time 
to test this hypothesis. 
 
5-7: Quality of life and 
hunger/satiety/food intake 
measurements are standard 
assessments in weight loss trials. 
 
8: Endoscopy results will be 
evaluated as a measure of safety to 
determine degree of ulceration and 
other potential gastric pathology. 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
9) 
Ghrelin expression in pre- and 
post-embolization fundal biopsy 
samples 
10) Changes in taste perception 
11) Analysis of image post 
procedure using CT: bead 
distribution, fundal coverage 
12) Embolization endpoint 
(occlusion, recanalization) 
10: Evidence in prior work indicates 
taste changes after bariatric 
surgery. 
 
11-12: Stasis and dosing in 
interventional radiology will be 
measured and compared to more 
traditional techniques to determine if 
image-visible embolics are more 
precise and safe and if degree of 
fundal coverage correlates with the 
procedure outcome. 
 
 
4 
STUDY DESIGN  
 
4.1 OVERALL DESIGN 
 
We hypothesize that transvascular bariatric embolization of the left gastric and/or gastroepiploic 
arteries will results in safe and effective weight loss in obese participants compared to control 
subjects.  
 
The BEATLES study is an investigator-initiated, prospective, phase 2, single-site, double-
blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization 
on the systemic hormonal levels of obesity and weight loss in 54 obese participants (BMI ≥35 
kg/m2) at post-procedure weeks 1 and 2, and months 1, 3, 6, and 12.  There will be 10 pilot 
patients (See Statistical Analysis below for sample size calculations) for a total of 59 
participants.  Participants will be followed with study outcomes assessed for a period of 12 
months. The duration of the study will be approximately three years. 
 
The goal of this study is to help treat obesity using a minimally invasive, angiographic (i.e., 
through blood vessels) approach. This study will be conducted under an FDA Investigational 
Device Exemption (IDE) to support the use of 100 – 200 µm BTG-001933 microspheres in 
bariatric artery embolization for the treatment of obesity. The BTG-001933 microsphere 
(Biocompatibles UK, LTD) is an investigational device based on the legally marketed LC Bead 
LUMITM (K152157, K162373), which has an approved indication for use of embolization of 
hypervascular tumors and arteriovenous malformations. The BTG-001933 microsphere is the 
result of modification of the LC Bead LUMITM with respect to bead size range and iodine content. 
These device modifications may facilitate and optimize imaging techniques associated with the 
planned procedure.  
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Due to the psychological basis for weight loss, a sham control procedure is required for 
comparison. All patients will receive weight management support, which is routine care for this 
patient population. 
 
4.3 JUSTIFICATION FOR DOSE 
 

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The standard embolization technique utilized for the study was chosen based on animal studies 
to create ischemia.  Ischemia is a reduction in blood flow, which is the mechanism that causes 
the cells in target area (fundal region of stomach) to down regulate ghrelin hormone production 
without necrosis. During the embolization process beads will be infused (under CT imaging) 
until stasis of anterograde arterial flow is achieved. It is believed that lower ghrelin levels result 
or correlate with suppressed appetite or lowered hunger response. 
 
4.4 END OF STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed all phases of 
the study including the last visit or the last scheduled procedure shown in the Schedule of 
Activities (SoA), Section 1.3. 
 
The end of the study is defined as completion of the last visit or procedure shown in the SoA in 
the trial globally. 
 
5 
STUDY POPULATION 
 
5.1 INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Male or female, aged ≥21 and ≤70 years 
2. Willing, able, and mentally competent to provide written informed consent 
3. Obese patients with a BMI ≥35 kg/m2  
4. Weight ≤400 lb 
5. Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of 
the interventional radiologist is amenable to bariatric embolization, as assessed via 3D 
CT angiography 
6. Suitable for protocol therapy, as determined by the interventional radiology investigator 
7. Adequate hematologic (neutrophils>1.5x109/L, platelets>70x109/L, INR<1.5), hepatic 
(bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated GFR>60mL/min. 1.73m2) 
function 
8. For females of reproductive potential: agreement to use of highly effective contraception 
for duration of study participation  
9. Patients who have failed conservative weight loss therapies such as supervised low-
calorie diets combined with behavior therapy and exercise 
10. Live or work within 65 miles of the enrolling institution in case a catastrophic post-
embolization event occurs 
 
5.2 EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
 
Exclusion Criteria (Medical): 
1) Hb A1c greater than 8% 

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2) Patients who are currently taking either Insulin or Sulfonylureas (medication changes are 
allowed) 
3) Prior history of gastric, pancreatic, hepatic, and/or splenic surgery 
4) Prior radiation therapy to the upper abdomen  
5) Prior embolization to the stomach, spleen, or liver  
6) Cirrhosis 
7) Known portal venous hypertension 
8) Active peptic ulcer disease 
9) Significant risk factors for peptic ulcer disease, including daily NSAID use  
10) Large hiatal hernia, defined as >5 cm in size 
11) Active H. pylori infection 
12) Known aortic pathology, such as aneurysm or dissection 
13) Renal insufficiency, as evidenced by an estimated glomerular filtration rate of <60 
mL/min 
14) Major comorbidity, such as active cancer, significant cardiovascular disease, or 
peripheral arterial disease  
15) Pregnancy 
16) Pre-existing chronic abdominal pain 
17) Positive stool occult blood study 
18) GI bleeding or bleeding diathesis within 5 years 
19) Weight loss (intentional or unintentional) of more than or equal to 5% of body weight in 
the 6 months prior to randomization 
20) A weight loss greater than 6lb during the weight management run-in 
21) Use of anti-obesity medications in the 12 months prior to screening.  
22)  
23) Endoscopic findings that would preclude BAE (at the discretion of the study team) 
24) History of gastric motility disorders or an abnormal nuclear gastric motility examination 
(to be performed in diabetic subjects only) 
25) 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 – this 
exclusion criterion exists, because of the possibility that surgical intervention will be 
needed if the study intervention subsequently leads to severe adverse effects   
26) Inflammatory bowel disease 
27) Autoimmune disease or HIV+ 
28) History of allergy to iodinated contrast media 
29) Failure to comply with pre-procedure weight management “run-in”, or other pre-
procedural visits (specifically, participants must complete 80% of weight management 
and Lose It! Food tracking, and 100% of one-time visits, i.e. MRI, CTA, endoscopy) 
30) Applicability of any contraindication regarding patient’s vasculature as per Instruction for 
Use 
31) Inability to have an MRI scan (i.e., metal implants or claustrophobia) 
32) Smokers/vapers/tobacco use 
33) Active or new-onset endocrine disorders other than diabetes (stable disease acceptable) 
34) Other unforeseen conditions that may make patients unsuitable for the procedure (study 
team discretion) 
 
Exclusion Criteria (Psychiatric): 
35) As determined by clinical judgment based on Clinical Interview, psychological/behavioral 
measures, medical records, previous mental health records/other collateral information 
(as available) and consistent with DSM -5 criteria: 

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36) Diagnosis of severe mental illness (i.e., chronic psychotic spectrum disorders, clinically 
significant mood disorders) AND/OR one or more of the following: 
o Evidence of active relapse or active impairing symptoms (e.g., suicidal ideation, 
audio or visual hallucinations, paranoia, thought disturbance, severe impairment) 
o Evidence of minimal supports or limited adherence to ongoing mental health care  
o Failure to provide comprehensive aftercare plan that includes emergency plan for 
addressing future mental health relapse 
o History of treatment refractory mental illness/recurrent relapse (multiple suicide 
attempts or inpatient psychiatric hospitalizations in the past 5 years) 
o Within past 3 years: Inpatient psychiatric hospitalization  
o Within past 5 years: Suicide attempt  
o Declining to provide mental health records, a letter of support from mental health 
professionals, or consent for verbal consultation with mental health professionals 
when determined to be essential to evaluation. 
o Cognitive impairment, if judged to have 
o Limited capacity to make informed decision about procedure and inability to 
verbalize an understanding of the surgical procedure, risks and benefits. 
o Inability to demonstrate an understanding of the permanency of lifestyle change 
required 
o History of Anorexia or History of/Active Bulimia: If determined to be of low 
enough severity not to be a clear contraindication, minimum of 5 years 
abstinence from bulimia; current moderate to severe binge eating or night eating 
syndrome 
o Active or History of Substance Abuse with less than 5 years of abstinence  
o Current use of tricyclic anti-depressants or steroids, psychiatric medications 
associated with weight gain 
 
5.3 LIFESTYLE CONSIDERATIONS 
 
During this study, participants are asked to: 
 
• 
Undergo medical therapy consisting of lifestyle counseling and weight management.  
• 
Diabetic subjects will have their medications managed by their diabetes specialist, per 
routine care, as defined by American Diabetes Association guidelines.  
• 
Eat nothing after midnight prior to their clinic visits.  
• 
Agree to use birth control for the duration of the study (women of fertile age). 
• 
Avoid use of tobacco products for the duration of the study.  
 
5.4 SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in the clinical trial but are 
not subsequently randomly assigned to the study intervention or entered in the study. A minimal 
set of screen failure information is required to ensure transparent reporting of screen failure 
participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing 
requirements and to respond to queries from regulatory authorities. Minimal information includes 
demography, screen failure details, eligibility criteria, and any serious adverse event (SAE). 
 

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Individuals who do not meet the criteria for participation in this trial (screen failure) because of 
medications or other modifiable conditions (including but not limited to weight changes, non-
cancerous failed endoscopy, active H. Pylori infection, uncontrolled glucose) may be 
rescreened. Rescreened participants should be assigned the same participant number as for 
the initial screening. 
 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
The targeted patient cohort is men and women aged between 21 and 70 years of various racial 
and ethnic backgrounds. Vulnerable patients (pregnant women, those who lack consent 
capacity, prisoners, children, employees, etc.) will be excluded as per the inclusion and 
exclusion criteria.  
 
It is anticipated that approximately 1300 patients will be pre-screened to enroll 59 eligible 
subjects (based on prior experience in the BEAT Obesity trial) over a 24-month period. All 
subjects will be enrolled at the Johns Hopkins Hospital. Pre-screening will utilize an existing 
registry of patients from previous trials and patient referrals (weight management clinic referrals 
and self-referrals from advertising campaign). Identified or referred patients will be screened by 
phone using a telephone script.  
 
Subjects will be followed for a period of 12 months. Retention strategies will include collecting 
multiple methods for contacting each participant and visit reminders. Subjects will receive 
payments of up to $945 after the bariatric embolization (or control) procedure per the 12-month 
period, using the payment scheme tabulated below. Payment is given at 5 different intervals.  
Each test or log must be completed within the allotted range in order to receive payment. 
Payment may be prorated for weight management visits. For example, if a participant attended 
4 weight management visits instead of 5 during weeks 4-8, they may receive $40 during that 
time. 
 
Weeks 1-3 
Weeks 4-8 
Months 3-5  
Months 6-11  
Month 12  
Food Log 
$30 
Food Log 
$20 
Food Log 
$20 
Food Log 
$30 
Food Log 
$40 
Hunger Satiety 
$30 
Hunger Satiety 
$20 
Hunger Satiety 
$20 
Hunger Satiety 
$30 
Hunger Satiety 
$50 
Hormone Test 
$20 
Hormone Test 
$30 
Hormone Test 
$35 
Hormone Test 
$40 
Hormone Test 
$50 
 
 
MRI 
$45 
MRI 
$50 
MRI 
$50 
Endoscopy 
$70 
Weight Mgmt. 
(3 visits) 
$40 
Weight Mgmt. 
(5 visits) 
$50 
Weight Mgmt. 
(6 visits) 
$55 
Weight Mgmt.  
(7 visits) 
$60 
Weight Mgmt. 
(1 visit) 
$5 
Blood Tests 
$10 
Blood Tests 
$10 
Blood Tests 
$10 
Blood Tests 
$10 
Blood Tests 
$15 
Total 
$130 
Total 
$130 
Total 
$255 
Total 
$220 
Total 
$210 
 
Subjects who meet the entrance criteria will provide informed consent before being enrolled into 
the study. Consent will be obtained at the first visit at the Weight Management Center or 
Interventional Radiology. Participants will have as much time as necessary for giving consent. 

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Participants will have the study processes and consent form explained in detail, and then will be 
given time to read through the consent form. Participants will not be allowed to sign the consent 
form without reading through it first. Participants will be given the consent form in private; and 
probed for any potential questions they may have. A copy of the signed informed consent will be 
maintained and available for review by the Sponsor and designated monitor. 
 
6 
STUDY INTERVENTION 
 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
This study is being conducted under IDE G190208 utilizing an investigational device, BTG-
001933, which is a radiopaque embolic bead 100-200 µm (Biocompatibles UK, Ltd) intended to 
be used for bariatric embolization of the left gastric and/or gastroepiploic arteries. The summary 
of test validation studies is on file with the FDA and available in the Investigator’s Brochure.  
 
Control Arm Procedures 
Participants randomized to the control arm will follow the same screening and pre-procedure 
assessment, and will also take the same pre-procedure medications. After becoming eligible, 
participants will be scheduled for their procedure. On procedure day, the interventional 
radiologist will determine radial or groin access in the post-anesthesia care unit per local policy. 
After the participant and procedure area are prepped, and a basic tray is opened, all participants 
will be given standard moderate sedation medications. At this point, the participant will have a 
drape placed over a drape support above their face to limit their vision and be given ear plugs 
and noise-cancelling headphones to dampen their hearing, preventing them from seeing and 
hearing the procedure but still allowing them to keep in contact with the procedure team. The 
participant will be randomized to either the control or intervention arm using central 
randomization software. Participants randomized to the control arm will receive no other 
procedural intervention. The procedural team instead will follow a prescribed simulated protocol 
that will mimic an actual embolization procedure. All participants will receive subcutaneous 
lidocaine and a skin nick to their groin or their wrist as pre-determined by the operating 
physician in the pre-anesthesia care unit, including those randomized to the control arm. If the 
skin nick is on the wrist, the operating physician will close it with an external compression 
device, and if it is in the groin, the physician will hold pressure for at least 5 minutes. 
 
All procedure images and reports, regardless of the randomization arm, will be kept with the 
unblinded member of the study team, and will not be housed centrally. All participants will 
adhere to the same follow-up schedule, meeting with blinded members of the study team only. 
The procedural team will not have further contact with the participant, the participant will only be 
followed by the blinded study team. Once the study is closed, all reports and images will be 
entered into the clinical record.  
 
Bariatric Embolization Procedure 
The bariatric embolization procedure will be performed under moderate sedation by 
experienced interventional radiologists. This procedure will take about one-and-a-half to three 
hours. The manufacturer’s Instruction for Use will be followed for the procedure. 
 

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The participant will be placed on the X-ray fluoroscopy table. Radial or femoral vascular access 
will be achieved using a small 21-gauge needle, then dilated serially over a guidewire to 
accommodate a 5 French vascular sheath(23). The participant will receive local anesthesia in 
the skin of their leg or wrist, then a different small catheter will be placed through the 
participant’s skin into an artery that leads to the participant’s abdomen.   
 
Using standard catheters, 3-dimensional imaging will be acquired of the stomach, the arteries 
supplying the fundus arising off the celiac vessel will be selected. Then, a microcatheter will be 
advanced into the left gastric and/or gastroepiploic arteries supplying the fundus and small 
calibrated spheres (100-200 µm size [BTG-001933]) will be infused until stasis of anterograde 
arterial flow is achieved, with particular care to avoid infusion of non-target arteries. Only the left 
gastric and/or gastroepiploic arteries will be embolized. Stasis will be defined as visualization of 
contrast within the target artery for at least 5 cardiac cycles.  
 
Upon completion, repeat 3-dimensional imaging will be acquired to assess bead distribution and 
fundal coverage. Following this the catheters will be removed and hemostasis will be achieved 
with manual compression or a closure device. 
 
The participant will be monitored in the post-sedation recovery room until the participant meets 
the usual admission criteria, per local policy, followed by an overnight hospital admission for 
observation. During observation, intravenous fluids will be given to ensure adequate hydration 
status. If necessary, participants will be given analgesics, anti-nausea, and anti-emetic 
medication. If the participant continues to display pain, nausea, vomiting, etc., the participant 
may be kept in hospital for up to 48 hours post-procedure. The participant will be asked to avoid 
exertion for 48 hours following the procedure. Participants will adhere to a written post 
procedure diet plan consisting of a slow advancement from clear liquids, progressing to full 
liquids and finally solids. At which point they will be advanced to a regular diet as directed by the 
Weight Management Center. Please see post procedure diet plan in Appendix A.   
 
6.2 PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
 
Inventory of the BTG-001933 product will be maintained by the study team in a secure location 
with dispensing records completed to document supply receipt, dispensation, and return of 
unused product.  
 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
 
The BTG-001933 product is provided by the manufacturer (Biocompatibles UK, Ltd) packaged 
as individual cartons containing one vial of product and one ViaLok Vented Vial Access Device 
(Yukon Medical LLC). The vial and carton are labeled For Investigational Use Only.  

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The primary packaging material of the vial includes: 
 
Material 
Description 
10 ml glass vial 
10ml ISO Clear Type I Glass Vial with 20mm Crimp Neck 
Vial stopper 
20 mm fluoropolymer film coated bromobutyl rubber 
Injection stopper 4023/50 Grey B2-40 Westar® RS 
Flip-off tear-off crimp 
cap 
Aluminum cap with a colored plastic (polypropylene) 
button seal  
Size 100 – 200µm: red 
 
6.2.3 PRODUCT STORAGE AND STABILITY 
 
Based on the evidence of 24 months shelf life for LC Bead LUMITM and available 6 months real 
time and accelerated stability data for BTG-001933, an initial shelf life claim for the 
investigational device BTG-001933 for use in clinical studies of 18 months at 2 – 25°C has been 
defined. The shelf life will be extended based on the results of ongoing stability studies, if 
appropriate. 
 
The following storage conditions are defined for BTG-001933: 
• 
Unopened BTG-001933 must be stored between 2˚C to 25˚C, in a dry place in its original 
packaging. Protect the product from light.  
• 
Use by the date indicated on the vial label.  
• 
Do not freeze. 
 
6.2.4 PREPARATION 
 
The bead suspension of BTG-001933 in buffered saline is to be transferred from the vial into a 
10 mL syringe by using the transfer device prior to administration to the patient. The transfer 
device is supplied with the product and is co-packaged in the device carton with the BTG-
001933 vial. The transfer device (20 mm ViaLok Vented Vial Access Device (Yukon Medical 
LLC)) is a sterile medical device intended to access standard vials for needle-free preparation 
and administration. Details of product preparation are given in the manufacturer’s Instruction for 
Use. 
 

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6.3 MEASURES TO MINIMIZE BIAS: SITE TRAINING RANDOMIZATION AND 
BLINDING 
 
Of the 59 participants who will participate in this research, 27 participants will be randomized to 
the intervention arm, and 27 participants will be randomized to the control arm. The first 10  
patients to meet all eligibility criteria will be the 10 pilot patients; these patients will not be 
analyzed with the randomized patients. 
 
In this double-blind experiment, neither blinded study team nor participants will know the details 
of the participants’ randomization. Unblinded members of the study team will perform the 
procedure and have access to the medical record in case of emergency. All study visits 
involving study intervention and the details of the procedure, including start/stop times, will be 
recorded on the relevant eCRF by the unblinded team member. 
 
All participants will undergo the same preparation for the procedure, then, when the procedure 
begins, the participants will be blindfolded with a head drape and will have their hearing damped 
with ear plugs and noise-cancelling headphones, preventing them from seeing and hearing the 
procedure, but still allowing them to keep in contact with the procedure team. All procedure 
images and reports, regardless of the randomization arm, will be kept with the unblinded 
member of the study team, and will not be housed centrally. All participants will adhere to the 
same follow-up schedule, meeting with blinded members of the study team only. The procedural 
team will not have further contact with the participant, the participant will only be followed by the 
blinded study team.  
 
After all subjects complete the follow-up period, the study team and the subjects will each 
complete a survey to determine to which arm they thought each subject was randomized. After 
the surveys are completed, both the investigator and subject will be unblinded at the same time. 
Once the study is closed all reports and images will be entered into the clinical record. 
 
6.4 STUDY INTERVENTION COMPLIANCE 
 
Embolization and device placement will be assessed by radiographic imaging.  
 
Subject-completed logs recording diet, hunger levels, weight, and symptoms will be reviewed to 
determine compliance with the weight management intervention prior to the procedure and 
during the follow-up period. 
 
6.5 CONCOMITANT THERAPY 
 
The participant will be asked to take an oral proton pump inhibitor (Omeprazole 40 mg, daily) 
and an oral cytoprotective agent (Sucralfate 1 g, two times a day), which coats and protects the 
stomach lining for two weeks before and six weeks after the procedure to prevent stomach 
irritation. Participants suffering from diabetes will be asked to withhold their diabetes medication 
on the day of the procedure. 
 
Daily NSAID use should be avoided to reduce the risk for peptic ulcer disease.  
 

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At every study visit, new medications or changes in concurrent medications on the appropriate 
concurrent medication eCRF will be recorded. Documentation will include dosage, start/stop 
dates and any drug holidays.  
 
For this protocol, a prescription medication is defined as a medication that can be prescribed 
only by a properly authorized/licensed clinician. Medications to be reported in the Case Report 
Form (CRF) are concomitant prescription medications, over-the-counter medications and 
supplements. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
 
All decisions to stop the study in any subject, or the study as a whole, will be made by the 
DSMB, a multidisciplinary team. This team will include a gastroenterologist, psychologists, 
obesity specialist, bariatric surgeon, and interventional radiologists. If the DSMB decides to 
remove a subject, the investigator will refer the subject to necessary medical care for follow-up.  
 
The DSMB will halt the study for evaluation and possible discontinuation if one or more subjects 
experience any of the following events: 
• 
Gastric ulcerations which require endoscopic or surgical intervention 
• 
Gastrointestinal bleeding that reduces hemoglobin >3 gm/dL 
• 
Significant abdominal pain requiring hospitalization >48 hours post procedure 
• 
Inability to retain ingested fluid or solid food >48 hours post procedure due to persistent 
nausea and vomiting 
• 
Radiation overexposures 
• 
Any other unexpected organ injury that could be related to the procedure including but 
not limited to the following: abdominal abscess, bowel infarction or perforation, 
hypoxemia, azotemia, heart failure, pulmonary venous congestion, shock, deep vein 
thrombosis, pulmonary emboli or death  
 
Discontinuation from study intervention does not mean discontinuation from the study, and 
remaining study procedures should be completed as indicated by the study protocol.  If a 
clinically significant finding is identified (including, but not limited to changes from baseline) after 
enrollment, the investigator or qualified designee will determine if any change in participant 
management is needed. Any new clinically relevant finding will be reported as an adverse event 
(AE). 
 
The data to be collected at the time of study intervention discontinuation will include the 
following: 
 
• For subjects who withdraw before the end of the study, all End of Study assessments 
should be completed, if possible, prior to withdrawal. All AEs must be documented in 
the patient medical notes and in the electronic case report form (eCRF). 
• If a subject withdraws from the study for any reason, all efforts should be made to follow 
AEs unless the subject withdraws consent. 
 

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7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Subjects are free to withdraw from participation in the study at any time upon request. 
 
The DSMB will determine if stopping rules apply. Stopping rules that would necessitate 
withdrawal of any individual subject include development of any of the following conditions 
during the six-month period following the procedure. All efforts should be made to follow AEs to 
resolution or stabilization unless the subject withdraws consent: 
 
• 
Development of gastric ulceration observed at the follow-up endoscopy that requires 
surgical therapy. If ulceration can be managed medically, it will be treated by a 
gastroenterologist, and the participant will remain in 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, 
mesenteric venous thrombosis, deep vein thrombosis, pulmonary emboli, adhesions, or 
death. 
• 
Subjects may also be removed from the study by the investigator for the following 
reasons: 
o Staying in the study would be harmful to the subject (this includes new 
pregnancy during follow-up). 
o The subject needs treatment that is not allowed in the study. 
o It is decided that another therapeutic approach can improve the subject’s medical 
care. 
o The subject fails to follow instructions. 
o The subject is not complying with study visits. 
o The study is cancelled. 
o There may be other reasons to remove study subjects that are not known at this 
time. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
electronic Case Report Form (eCRF). Subjects who sign the informed consent form and are 
randomized but do not receive the study intervention may be replaced. Subjects who sign the 
informed consent form, and are randomized and receive the study intervention, and 
subsequently withdraw, or are withdrawn or discontinued from the study will not be replaced. 
 
7.3 LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for the final scheduled 
visit and is unable to be contacted by the study site staff. Attempts to contact will occur as below 
for all missed study visits. 
 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• 
The site will attempt to contact the participant, reschedule the missed visit within ±3 days 
for the weekly visits and within ±2 weeks for monthly visits, and counsel the participant 
on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study. 

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• 
Before a participant is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record and study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 STUDY PERIOD DEFINITIONS 
 
Baseline & Screening Period 
After initial eligibility is determined and informed consent is provided, participants will be 
assessed against all eligibility criteria over a two-month period. Initial lab results will be 
compared with repeat lab results obtained within 30 days of the embolization procedure to 
confirm eligibility. The signed consent form authorizes abstraction of existing data from a 
patient’s medical chart for data collection. Participants will be screened by two physicians, an 
interventional radiologist, and an internist who specializes in obesity. Screening and baseline 
visits may be combined if patient and physician schedules will allow. The screening phase 
begins when the informed consent is fully signed and dated and ends at randomization.  The PI 
may repeat any of the screening tests. 
 
Pre-Procedure Period 
This period begins after initial eligibility is determined during the Baseline & Screening Period 
and ends at randomization.  
 
Procedure Day 
This day is scheduled only after all eligibility criteria are satisfied during the previous periods.  
 
Follow-Up Period 
This period begins with day 1 post Procedure Day and ends at the final visit at month 12.  
 
Participants will be in the study for up to two years after signing consent and 12 months post 
embolization. Participants may be followed clinically for up to five years per routine care after 
the end of the study. For their 12 months of follow up post-procedure, the participants will be 
asked to come to clinic visits at weeks 1 and 2, and months 1, 3, 6, and 12.  
 
During each clinic visit the following may occur: 
• 
Participants will be evaluated by a study team member, data and home logs will be 
recorded and collected, will undergo a targeted history and physical exam, and will be 
asked to fill out any needed questionnaires.  
• 
When attending weight management visits, they will also be evaluated by an internist 
who specializes in weight management. 
• 
Medication changes will be documented. 
• 
Intensive medical therapy consisting of lifestyle counseling and weight management will 
be provided to all participants. Diabetic subjects will have their medications managed by 
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guidelines. Any changes in diabetes medication regimen will be documented in the 
electronic case report form. These data will be used to calculate a medication effect 
score (MES). 
• 
Participants will be asked to eat nothing after midnight prior to their clinic visits. 
 
8.2 STUDY ASSESSMENTS AND PROCEDURES DEFINITIONS 
8.2.1 Informed Consent 
See section 10.1.1 for a full description. 
 
8.2.2 Demographics 
The following demographic data will be obtained: date of birth/age, gender, child-bearing 
potential, race, ethnicity. 
 
8.2.3 History & Physical 
Medical history deemed clinically significant, relevant to the clinical trial objectives and design, 
will be collected per body system (allergy/immunology), auditory/ear, blood/bone marrow, 
cardiac arrhythmia, cardiac general, dermatology/skin), endocrine metabolic, gastrointestinal, 
hemorrhage/bleeding, hepatobiliary/pancreatic, infection, musculoskeletal/soft tissue, 
neurologic, ocular/vision, psychiatric, pulmonary/upper respiratory, renal/genitourinary, sexual 
reproductive function, vascular). 
 
The use of concurrent medications (medications taken within 30 days of screening and during 
the conduct of the study) will be obtained and documented in source documentation and on the 
relevant eCRF. 
 
All ongoing medical conditions and adverse events arising from treatment of those conditions 
present for 30 days or more are generally considered a part of the patient’s baseline medical 
history and must be recorded where indicated. 
 
A full physical examination, including actual measured height (required at screening only) and 
actual scale measured weight, will be performed by a qualified licensed individual. A review of 
body systems will include the following: 
• 
Waist circumference 
• 
General appearance, overall well-being and functional capacity 
• 
Skin 
• 
Head, Ears, Eyes, Nose, Throat (HEENT) 
• 
Respiratory 
• 
Cardiovascular 
• 
Abdomen (including liver, gastrointestinal system) 
• 
Musculoskeletal, extremities and mobility 
• 
Neurological 
• 
Vital signs: Assessments of vital signs (e.g., blood pressure, heart rate, temperature) will 
be performed at all study visits. When possible, blood pressure and heart rate will be 
determined after the patient has been in the sitting position for 5 minutes. Respiratory 
rate will only be obtained at baseline (i.e. at the weight management intake visit during 
screening). 
 

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A full physical examination as detailed above will be performed at baseline (weight management 
screening intake visit), 1-week, 2-weeks, and 1-month post-procedure. Vital signs, including 
weight, will be taken at all visits with weight management, however, waist circumference will 
only be measured at the weight management intake visit (screening period), on procedure day, 
and at the 1-month, 3-month, 6-month, and 12-month post-procedure weight management 
follow-up visits. 
 
Any abnormalities or changes in intensity, duration or frequency not noted during the initial 
review of body systems should be documented in the source documentation and reported 
appropriately in the eCRF. If a new clinically significant finding, or if a change occurs at 
subsequent visits, the new finding must be assessed for adverse event criteria and will be 
documented. Resolution of any abnormal findings reported during the study will be noted in the 
source documentation and the eCRF. 
 
8.2.4 Psychological Evaluation 
• 
Before - A psychological evaluation will be completed and scored prior to the first visit. A 
screening form will be used utilizing inclusion and exclusion criteria to avoid further 
unnecessary testing. The initial evaluation will be, on average, 1.5 hours. 
 
After - Follow-up visits are usually 1 hour and will largely depend on the plan with the Johns 
Hopkins Healthful Eating, Activity & Weight Program and the degree to which the participant 
presents with psychopathology that requires follow-up.  Participants will meet with the same 
study psychologist with whom they did their initial screening 2-4 weeks after the procedure, and 
develop a follow-up plan which will be adjusted to suit each individual participant’s needs. At a 
minimum, this will include scheduled visits at 1, 3, 6, and 12 months; follow-up visits may be 
conducted more frequently than specified (i.e. optional 9-month visit) or completed remotely (i.e. 
telehealth) if clinically indicated—this will be at the discretion of the study psychologists. 
The participant will follow up with the same psychologist who conducts the initial evaluation, 
except in urgent or emergency situations in which that psychologist is not available. 
 
8.2.5 Blood, Urine, and Stool Tests 
Blood tests including complete blood count, tests of liver and kidney function, serum albumin 
measurement, electrolytes, urea, creatinine measurements (EUC), and fasting chemistries, 
including glucose and insulin, will be performed at screening (and again before the procedure if 
the screening blood tests were done more than 30 days before the procedure) and every study 
visit thereafter (week 1, week 2, week 4, month 3, month 6, month 12). 
 
A stool occult blood test to identify gastrointestinal bleeding and H. pylori blood antibody test to 
see if the participant has been exposed to a specific type of bacteria that can cause stomach 
ulcers will be performed only at screening. 
All clinical laboratory assays will be performed at the Johns Hopkins CORE laboratory according 
to the laboratory’s normal procedures. Reference ranges will be supplied by the laboratory and 
used to assess the laboratory data for clinical significance and out of range pathological 
changes. Abnormal laboratory values which are unexpected or not explained by the patient’s 
clinical condition should be repeated until confirmed, explained or resolved. Changes from 
screening will be recorded as an adverse event if clinically significant. 
 
The following clinical laboratory assessments will be completed at specified study visits during 
the study.  
 

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Biochemistry 
• 
Sodium 
• 
Potassium 
• 
Calcium 
• 
Blood Urea Nitrogen 
• 
Creatinine 
• 
Albumin 
• 
Total Protein 
• 
Aspartate transaminase (AST) 
• 
Alanine transaminase (ALT) 
• 
Alkaline phosphatase (ALP) 
• 
Total and indirect bilirubin 
• 
Glucose 
• 
Lactate Dehydrogenase (LDH) 
• 
Insulin  
• 
Pancreatic enzymes: Amylase and Lipase 
 
 
 
Coagulation 
• 
Prothrombin Time (PT) 
• 
Partial Thromboplastin Time (PTT) 
• 
International Normalized Ratio (INR) 
 
Hematology 
• 
Hemoglobin 
• 
Hematocrit 
• 
White Blood Cell (WBC) Count  
• 
Platelet Count 
• 
WBC Differential and ANC 
• 
Red Blood Cell (RBC) Count  
• 
Mean corpuscular volume (MCV) 
 
Lipid Profile
• 
Low-Density Lipoprotein (LDL) 
• 
High-Density Lipoprotein (HDL) 
• 
Triglycerides 
• 
Total Cholesterol 
• 
Total Cholesterol: HDL Ratio 
• 
Non-HDL Cholesterol 
 
8.2.6 Pregnancy Test 
A urine or serum beta hCG pregnancy test will be performed on all females of child-bearing 
potential as a part of the screening process. If the participant is a woman who is able to become 
pregnant, she will have a repeat pregnancy test on the day of or the day before the embolization 
procedure. The result of this test must be negative for her to continue in the study.  Women of 
fertile age must agree to use birth control for the duration of the study. Pregnancy tests will also 
be performed within a week of endoscopies and nuclear medicine gastric emptying tests. 
 
Pregnancy: any report of complications of pregnancy such as miscarriage or congenital 
abnormality recorded for any female study participant or female partner of a male study 
participant should be reported immediately as an SAE. Participants will be asked to use 
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participant will be removed from the study. Every effort should be made to gather information 
regarding the pregnancy outcome until 8 weeks post-partum. It is the responsibility of the 
Investigator to obtain all pregnancy information. 
 
8.2.7 3D CTA 
A 3D CT angiography will be done to check the celiac and gastric vasculature.  We plan to 
embolize only the left gastric and/or gastroepiploic arteries.      
 
8.2.8 Gastric Emptying 
Subjects who suffer from diabetes will have a screening gastric emptying (gastric 
motility/emptying) scan. The result of this scan should be normal for the subject to be able to 
continue. After the embolization, should any participant present with symptoms of delayed 
gastric emptying, the PI will order another gastric emptying scan. 
 
8.2.9 Endoscopy with Biopsy 
An upper GI endoscopy, also known as esophagogastroduodenoscopy (EGD) will be done to 
determine any contraindication for the study and to determine the presence of ulceration or any 
other adverse event (AE).  
 
The endoscopy is also done to determine the health of the GI tract pre- and post-embolization.  
During the endoscopy, a long, flexible, lighted tube, called an endoscope, is guided through the 
patient's mouth and throat, then through the esophagus, stomach, and duodenum. A video 
camera in the endoscope will be utilized to inspect organs and detect abnormalities.  Pre-
procedure and post-procedure biopsies will be obtained to look at hunger hormone (ghrelin) 
levels in the stomach. Specifically, the biopsy will be accomplished using a device that looks like 
a small alligator clip at the end of the endoscope which will close over a very small sample of 
stomach tissue and allow for its extraction. In the case that an ulcer, inflammation, or mass is 
noted on endoscopy, additional biopsies may also be taken for further analysis of those regions. 
 
Endoscopic images will be described using standard clinical terms, which include size, location, 
and depth of observed ulceration. All endoscopy images will be recorded, archived, and 
reviewed by the same advanced endoscopist.  
 
8.2.10 Quality of Life Questionnaires 
A Quality of Life instrument suitable for the general population and patients being treated for 
obesity will be administered at study visits specified in the schedule of events.  
 
The Impact of Weight on Quality of Life (IWQOL) questionnaire is the first questionnaire 
developed to specifically assess the effects of obesity on health-related quality of life. The 
psychometric properties of the IWQOL are excellent, but given its length, a briefer version was 
developed, the Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite). The five 
identified scales (Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work) and 
the Total score have demonstrated excellent reliability (0.90–0.94 for the scales, 0.96 for Total 
score), validity, and utility with various groups of obese individuals. In this chapter, the rationale 
for the development of an obese-specific quality of life measure will be briefly reviewed, followed 
by the background and development of the IWQOL and IWQOL-Lite (including their 
psychometric properties), weight loss research using these instruments, and future research 
directions. It is concluded that the IWQOL-Lite is a reliable, valid instrument that can be utilized 
in various obese populations, and may be particularly useful as a treatment outcome measure. 

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8.2.11 Hormone Tests 
Fasting levels of obesity-related hormones will also be measured from patient’s blood. These 
will include such hormones as ghrelin, LEAP2, GLP-1, PYY, CCK, leptin, etc.  
 
 
8.2.13 MRI (with AMRA Profiler) 
A semi-automated cloud-based image analysis tool, AMRA Profiler, optimizes MR images to 
fully analyze entire body compartments, and provide precise body composition measurements. 
AMRA Profiler uses quantitative fat and water separation to integrate the total fat signal intensity 
in a compartment of interest; and provide a three-dimensional approach to improve the 
robustness of the segmentation. This system is quick, cost effective, validated, and 
reproducible. The automated single scan computes multiple measurements, and is completed in 
six minutes using fewer coils, no radiation, or contrast. MRI scans with body composition 
analysis will be performed before the bariatric embolization procedure, and four times over 12 
months after the procedure, at weeks 4, and months 3, 6, and 12. A standard 1.5T or 3T 
scanner with AMRA Profiler will be used to quantify visceral adipose tissue (VAT), abdominal 
subcutaneous adipose tissue (ASAT), thigh muscle volume, proton-density liver fat fraction, total 
adipose tissue volume (TAT), total lean tissue volume (TLT), muscle group volumes, 
intramuscular adipose tissue (IMAT), and individual muscle volumes. The data will be analyzed 
in conjunction with weight and HbA1c in order to see what patients will be suitable in the future 
for this procedure to determine which participants are suited and will benefit most from this 
procedure. As possible characterization of fat will be performed. In addition to the MRI with 
AMRA Profiler, the scan will also include Siemens work-in-progress sequences for evaluating 
fatty acid composition. Overall, the MRI is expected to take 30-38 min per session. 
 
8.2.14 Weight Management Counseling 
• 
Before – Following consent, the participant will have a total of eight visits over the 2-
month screening period with the weight management team at the Johns Hopkins 
Greenspring Campus Healthful Eating, Activity & Weight Program. This will include an 
initial 1-hour intake with a physician, consisting of a detailed review of medical history 
and a physical exam, followed by 7 weekly 15-minute meetings with either a physician 
as follow-up or other medical staff for weight checks. After their intake visit, reasonable, 
controlled diet plan will be outlined for the participant. Some visits may occur using a 
secured telemedicine link (see supplemental form). 
 
After – The first two months after the procedure, participants will have weekly visits with the 
Johns Hopkins Healthful Eating, Activity & Weight Program (HEAWP), alternating between 
visiting with a HEAWP physician and a weight check each week. In months 3 to 5, they will have 
a visit with a HEAWP physician every other week (i.e. two visits a month). In month 6, they will 
have one visit with a HEAWP physician and one visit with other medical staff at the clinic for a 
weight check. Lastly, from month 7 to 12, they will only have monthly visits with a HEAWP 
physician. Each follow-up visit should take around 15 minutes. 
 
8.2.15 Randomization 
Data documenting demographic information, medical history, physical examination, medication 
and prior treatment, clinical labs, pregnancy test, and urinalysis will be reviewed against the 
eligibility criteria to determine eligibility. The determination will be recorded on the relevant 
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If a patient is determined to be eligible to participate in the study, the patient will be randomized.   
 
Randomization will be determined using assignment by a computer-generated randomization 
scheme. Upon randomization/enrolment, each patient will be assigned a unique numeric patient 
identity code. 
 
8.2.16 Bariatric Embolization/Sham Procedure 
See section 6.1.1. 
 
8.2.17 CT 
Upon completion of the embolization procedure, a CT scan will be acquired to assess bead 
distribution and fundal coverage.  
 
8.2.18 Assessment of AEs 
Patients will be required to report adverse events spontaneously. At every study visit, staff will 
ask general, open-ended, non-directed questions to obtain information about AEs. If the patient 
is unable to attend a study visit, AEs can be collected by telephone contact. 
 
At any time during the study, the patient may volunteer information that resembles an AE. The 
Investigator should obtain all the information required to complete the AE form. Where possible, 
a diagnosis, rather than a list of signs or symptoms, should be recorded. Any medical 
management of an event and the resolution of an event must be recorded in source 
documentation and on the appropriate eCRF using medical terminology according to Sponsor 
instructions.  
 
The Investigator will assess all AEs for grading, severity and relationship to study treatment(s) 
and/or procedure(s). Definitions and procedures for assessment can be found in Section 8.3. 
 
8.2.19 Food Logs, Eating Behaviors, and Taste Preferences 
• 
The food log component of our study involves two factors: Lose It! food tracking and the 
ASA24 questionnaire. The Lose It! food log will be used for intervention purposes as 
well as general data tracking, as participants will be asked to fill it out on a daily basis, 
while the ASA24 will be used to obtain more standardized information regarding the 
subject’s eating behavior, and will be conducted over the phone at the specified 
timepoints in the study calendar.  
 
8.2.20 Hunger Satiety Scale 
This scale is a 6-day appetite evaluation that will be collected at the specified timepoints in the 
study calendar.  
 
8.2.21 HealthReel  
The HealthReel app will be used by patients to measure and track changes in their body 
composition throughout the study.  
    
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
Definition of Adverse Events (AE) and Adverse Device Effects (ADE)  
 

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Adverse event (AE) means any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether or not related to the investigational medical device. 
An adverse device effect (ADE) is an AE, as previously defined, related to the use of an 
investigational medical device. This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, the installation, the 
operation, or any malfunction of the investigational device. This includes any event that is a 
result of a use error or intentional abnormal use of the investigational medical device. 
 
8.3.1 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) AND SERIOUS 
ADVERSE DEVICE EFFECTS (SADE)  
 
A serious adverse event (SAE) is an adverse event that: 
a) Led to a death, injury or permanent impairment to a body structure or a body function. 
b) Led to a serious deterioration in health of the subjects, that either resulted in: 
a. A life-threatening illness or injury, or 
b. A permanent impairment of a body structure or a body function, or 
c. In-patient hospitalization or prolongation of existing hospitalization, or 
d. In medical or surgical intervention to prevent life threatening illness. 
c) Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
 
Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, 
without a serious deterioration in health, is not considered a serious adverse event.  
 
A Serious Adverse Device Effect (SADE) is an adverse device effect that has resulted in any of 
the consequences characteristic of a SAE, as previously defined.  
 
An unanticipated serious adverse device effect (USADE) is a serious adverse device effect, 
which by its nature, incidence, severity or outcome has not been identified in the current version 
of the protocol or Investigator’s Brochure. This includes unanticipated procedure-related serious 
adverse events; that is serious adverse events occurring during the study procedure that are 
unrelated to any malfunction or misuse of the investigational medical device. 
 
8.3.2 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.2.1 SEVERITY OF EVENT 
 
For adverse events (AEs) not included in the protocol defined grading system, the following 
guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities. (Equivalent to Grade 1 events if using CTCAE reporting) 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. (Equivalent 
to Grade 2 and 3 events if using CTCAE reporting) 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
(Equivalent to Grade 4 events if using CTCAE reporting)  

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8.3.2.2 RELATIONSHIP TO STUDY PROCEDURE 
 
All adverse events (AEs) must have their relationship to investigational device and/or procedure 
assessed by the clinician who examines and evaluates the participant based on temporal 
relationship and his/her clinical judgment. The degree of certainty about causality will be graded 
using the categories below. In a clinical trial, the study product must always be suspect.  
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event, including an abnormal 
laboratory test result, occurs in a plausible time relationship to study intervention 
administration and cannot be explained by concurrent disease or other drugs or 
chemicals.  
• 
Probably Related – There is evidence to suggest a causal relationship, and the 
influence of other factors is unlikely. The clinical event, including an abnormal laboratory 
test result, occurs within a reasonable time after administration of the study intervention, 
is unlikely to be attributed to concurrent disease or other drugs or chemicals. 
• 
Possibly Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after administration of the investigational device 
and/or procedure). However, other factors may have contributed to the event (e.g., the 
participant’s clinical condition, other concomitant events). Although an AE may rate only 
as “possibly related” soon after discovery, it can be flagged as requiring more 
information and later be upgraded to “probably related” or “definitely related”, as 
appropriate. 
• 
Not Related – The AE is completely independent of study intervention administration, 
and/or evidence exists that the event is definitely related to another etiology. There must 
be an alternative, definitive etiology documented by the clinician.] 
 
An AE becomes an ADE when the AE is considered if the attribution is possibly, probably or 
definitely related associated with the use of the test device.   
 
8.3.2.3 EXPECTEDNESS  
 
The investigator will be responsible for determining whether an AE is expected or unexpected 
based on the device labelling and Investigator Brochure.  An AE will be considered an 
unanticipated adverse device effect (UADE) if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the investigational device and/or 
procedure. 
8.3.3 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND 
FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the 
attention of study personnel during study visits and interviews of a study participant presenting 
for medical care, or upon review by a study monitor. In this study, patients should be 
encouraged to report AEs spontaneously or in response to general, non-directed questions.   
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured 
on the appropriate case report form (CRF). Information to be collected includes event 

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description, time of onset, clinician’s assessment of severity, relationship to investigational 
device and/or procedure (assessed only by those with the training and authority to make a 
diagnosis), and date and time of outcome of the event. All AEs occurring while on study must be 
documented appropriately regardless of relationship. All AEs will be followed to adequate 
resolution or stability. 
 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
 
The investigator or designee will record all reportable AEs (includes AE, ADE, SAE, SADE, 
UADE) with start dates occurring any time after exposure to the investigational device. An AE 
occurring after informed consent and prior to exposure of the investigational device will be 
added to the subject’s history. All AEs will be collected through the last day of study 
participation. At each study visit, the investigator will inquire about the occurrence of AE/SAEs 
since the last visit.  Events will be followed for outcome information until resolution or 
stabilization. 
 
8.3.4 ADVERSE EFFECT REPORTING 
 
Adverse events will be recorded on the AE eCRF. The Investigator or physician sub-Investigator 
will judge the severity of each AE and whether or not it is treatment-related. All AEs that occur 
after signing of informed consent including events likely to be related to the underlying disease 
or likely to represent concurrent illness, will be reported, including events present at Baseline 
which worsened during the study.   
 
The Investigator will be responsible for informing the IRB and reporting annually to the FDA as 
outlined in 21 CFR 812. 
 
8.3.5 SERIOUS ADVERSE EFFECT REPORTING  
 
Any SAE, SADE or UADE must be reported by telephone or fax to the Sponsor or it’s designate 
as specified in the study procedures within 24 hours of learning of the event. In the event of an 
emergency, the Investigator will contact the Sponsor safety officer using the coordinates 
specified in the study procedures manual. 
 
Each AE reported on an SAE form must also be reported in the AE section of the eCRF. 
 
The study investigator shall complete the SAE eCRF and submit to the study sponsor and to the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect. The entire SAE form needs to be 
completed, if possible, to keep requests for additional information to a minimum. Patients 
experiencing SAE, SADE or UADE should be followed clinically and with laboratory studies, if 
appropriate, until medical treatment and/or medical monitoring of the event is no longer required 
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be attributed to agents other than the study treatments or a referral for appropriate follow-up 
care has been made. 
 
The Principal Investigator, who is also the study sponsor for this study, is responsible for 
conducting an evaluation of a UADE and shall report the results of such evaluation to the Food 
and Drug Administration (FDA) in accordance with 21 CFR 812 and to the reviewing IRB within 
10 working days after the sponsor first receives notice of the effect. Thereafter, the sponsor 
shall submit such additional reports concerning the effect as FDA requests. 
 
8.3.6 REPORTING EVENTS TO PARTICIPANTS  
 
Participants will be informed of any new information that may affect their decision to continue 
participation after IRB approval.  
 
8.3.7 REPORTING OF ADVERSE EVENTS TO THE MANUFACTURER 
 
All SAEs and UADEs will be reported to BTG within 24 hours of becoming aware of the event by 
emailing a copy of the CRF to Vigilance@btgplc.com  The Investigator/Sponsor is responsible 
for obtaining any data BTG requires to complete the investigation of the event.  
 
A full listing of non-serious AEs will be provided to BTG at the conclusion of the study. 
 
8.3.8 REPORTING OF PREGNANCY  
 
Any report of pregnancy or complications of pregnancy such as miscarriage or congenital 
abnormality recorded for any female study participant or female partner of a male study 
participant should be reported immediately as an SAE. Participants will be asked to use 
contraceptives for the duration of the study, but if they become pregnant during the study, the 
participant will be removed from the study. Every effort should be made to gather information 
regarding the pregnancy outcome until 8 weeks post-partum. It is the responsibility of the 
Investigator to obtain all pregnancy information. 
 
Reporting procedures for SAE will be followed as outlined in section 8.3.6. 
 
8.4 UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
An UP could include an unanticipated adverse device effect, any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects (21 CFR 812.3(s)). 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING 
 

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The investigator will report unanticipated problems (Ups) to the reviewing Institutional Review 
Board (IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP 
report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the 
DCC/study sponsor within 24 hours of the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB and to the DCC/study sponsor within 10 days of 
the investigator becoming aware of the problem.  
• 
All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or designee), 
and the Office for Human Research Protections (OHRP) within 10 days of the IRB’s 
receipt of the report of the problem from the investigator.] 
 
An investigator shall submit to the sponsor and to the reviewing Institutional Review Board (IRB) 
a report of any unanticipated adverse device effect occurring during an investigation as soon as 
possible, but in no event later than 10 working days after the investigator first learns of the effect 
(21 CFR 812.150(a)(1)). A sponsor who conducts an evaluation of an unanticipated adverse 
device effect under 812.46(b) shall report the results of such evaluation to the Food and Drug 
Administration (FDA) and to all reviewing IRB's and participating investigators within 10 working 
days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit 
such additional reports concerning the effect as FDA requests (21 CFR 812.150(b)(1)).    
 
9 
STATISTICAL CONSIDERATIONS  
 
The statistical analysis plan will be a separate document and will be updated as required, in 
association with any protocol amendments. The plan will include descriptions of tables, listings 
and figures and will describe statistical programming considerations. 
 
9.1 STATISTICAL HYPOTHESES 
 
Statistical hypothesis:  
 
The mean weight loss from baseline at 12-months post-randomization in the BAE arm will be 
statistically significantly (2-sided p-value <0.2) greater than in the sham arm.  Since this is a 
phase 2 study, it is appropriate to use a two-sided p-value greater than the standard 0.05 value 
(see below). 
 
9.2 SAMPLE SIZE DETERMINATION 

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Sample sizes per randomized treatment arm for the proposed study are based on providing 
sufficient power for testing the primary hypothesis that BAE leads to larger mean weight loss 
from baseline than a sham procedure.  
 
Based on previous data, it is anticipated that the mean weight loss from baseline at 12-months 
post-randomization in the BAE arm will be at least 8 kg.(21, 36, 37) In contrast, we expect that 
participants in the sham arm will lose 3.3 kg at 12 months (corresponding to 3% weight loss 
from a baseline weight of 110 kg). Also, a common standard deviation for the change in weight 
from baseline at 12 months of 7 kg is assumed based on the data from the prior BEAT Obesity 
trial. Using a two-sample t-test and a two-sided alpha of 0.2, 21 participants in each arm will 
provide 80% power. The sample size is increased to 27 participants in each arm (i.e. a total of 
54 randomized participants) to take account of an expected 20% drop-out rate by the time of the 
12-month assessment.  Since this is a phase 2 study, it is appropriate to use a two-sided alpha 
greater than the standard 0.05 value. 
 
9.3 POPULATIONS FOR ANALYSES 
 
Statistical analyses will follow the intent-to-treat paradigm, meaning all participants will be 
analyzed according to the treatment group to which they were randomized. However, we will 
also perform an analysis according to a modified intention-to-treat (mITT) paradigm. As defined 
here, mITT means that all participants will be analyzed based on the treatment arm to which 
they were randomized, provided that they had exposure to the treatment protocol in their 
assigned arm. Participants who are randomized to a particular treatment arm, but who do not 
receive exposure to this treatment will be considered as ‘mis-randomized’, and will not be 
included in the mITT population. Reasons for participant mis-randomization include: 1) 
discovering post-randomization that a given participant does not meet the inclusion / exclusion 
criteria and is subsequently withdrawn from the study, 2) a participant refuses treatment after 
randomization, 3) a clinical investigator refuses to treat a participant post-randomization 
according to the protocol for the treatment arm to which the participant was assigned for any 
reason, and 4) the participant withdraws from the study post-randomization, but prior to 
receiving exposure to study treatment, for any reason. 
 
The ten pilot participants recruited in the proposed trial will not be analyzed with the participants 
recruited through randomization. Rather, these ten pilot participants will be used to test and 
refine the trial protocol, and data collection procedures.  
 
9.4 STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
As a first step, descriptive statistics will be performed, and the normality of continuous variables 
evaluated using the Shapiro-Wilk test and through exploratory plots (e.g. histograms and Q-Q 
plots). Non-normal variables will be transformed to normality, using appropriate data 
transformations, or will be analyzed using non-parametric statistical methods. Frequency 
distributions, tabulations, and bar charts will be created to quantify categorical and binary 
variables. These exploratory analyses will help us assess data distributions, and also help 
identify any unusual, outlying or suspect observations. Next, initial confirmatory analyses will be 
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variables between treatment arms, as well as between any comparable outside groups. These 
confirmatory analyses will include t-tests for continuous variables deemed to be normally 
distributed, or the non-parametric Wilcoxon Rank Sum test for non-normally distributed 
continuous variables. Binary and categorical variables will be analyzed using the Chi-Square 
goodness-of-fit test, or the Fisher’s Exact Test, appropriate for categorical variables with small 
cell sizes. A lack of differences between treatment arms will be considered as evidence of 
adequate randomization; however, we expect that some baseline covariates will be imbalanced 
by treatment arm, given the small size of this study, due to chance. 
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
The primary efficacy outcome for the proposed trial is total weight loss from baseline weight at 
12-months post-randomization. Differences in the weight loss from baseline between the 
treatment arms will be compared using the two-sample t-test. In addition, we will also consider 
an ANCOVA model that looks at the group difference in mean weight loss from baseline, 
adjusting for baseline covariates that might be imbalanced by treatment arm. 
 
Missing Data: As described above, we will be developing protocols to maximize follow-up. Our 
overall approach is to engage participants early on and keep them engaged through personal 
contact with the local center and access to information and resources that are relevant to them, 
their injury and their treatment. Furthermore, we do not expect the rates of missing data will be 
differential across treatment groups. As with most prospective studies, missing data will be 
unavoidable (even with excellent follow- up).  Since the informative nature of missing data 
cannot be verified from the observed data, we will adopt a sensitivity analysis framework for 
reporting results. We will analyze data under a variety of modeling assumptions regarding how 
strongly the missingness mechanism is related to outcomes (see Rotnitzky, A, Scharfstein, DO, 
Su, TL, Robins, JM (2001). “Methods for conducting sensitivity analysis of trials with potentially 
non-ignorable competing causes of censoring.” Biometrics, 57: 103-112). 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Secondary outcomes include:  
 
1) Change in body weight at timepoints other than 12 months 
2) Percentage change in body weight 
3) Achievement of a >5% reduction in body weight 
4) Percentage of excess weight loss (EWL) 
5) Change in multi-compartment body fat composition as measured by MRI 
 
Differences by treatment arm in the proportion of participants with >5% weight loss will be 
statistically compared using the Chi-square goodness-of-fit-test. Risk differences and relative 
risks, along with corresponding 95% confidence intervals, will be calculated to quantify group 
differences in this endpoint.  
 
9.4.4 SAFETY ANALYSES 
 
The primary safety endpoint will be the differences in adverse events at 12 months post 
procedure. The statistical analysis on the secondary outcome for safety will consider differences 
in the adverse events (AEs) at 30-days post-procedure.  
 

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9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
The BAE and sham groups will be compared on baseline characteristics, including 
demographics and laboratory measurements, using descriptive statistics such as mean, 
median, inter-quartile range, absolute values and percentages.  
 
9.4.6 PLANNED INTERIM ANALYSES  
 
An interim analysis of safety and technical utility of the embolic device (image visibility) and 
procedural assessments such as blinding, will be done after the 10 pilot patients complete the 
embolization procedure.  Study reports on device/ procedure related complications are to be 
sent to the FDA following treatment of the ten (10) pilot patients and then after every 10 
additional subjects are randomized and treated (blinded).  
 
No interim analysis for efficacy or futility are planned.  
 
9.4.7 SUB-GROUP ANALYSES 
 
All primary, secondary, and safety analyses will be performed by gender, race, and ethnicity to 
determine if the treatment effect or safety differs by these demographics. Patient-specific clinical 
or “severity” factors/categories and treatment categories will be explored. Planned explorations 
include diabetic status, age, compliance with weight management, baseline ghrelin levels, and 
post-procedure imaging characteristics.  
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Individual participant data will not be listed. Only aggregate data will be reviewed.  
 
9.4.9 EXPLORATORY ANALYSES 
 
Several tertiary endpoints will be considered in the proposed trial as stated before including 
blood pressure values, lipid profiles, serum obesity hormones, food intake, hunger 
assessments, QoL measures, and changes in taste perception. These endpoints will be 
quantified using a variety of assessment tools with both continuous and categorical scores. 
Statistical differences by treatment in these assessments will include the two-sample t-tests for 
continuous scores that are normally distributed, or the non-parametric Wilcoxon Rank Sum test 
for non-normally distributed continuous scores, while the binary and categorical scores will be 
analyzed using the Chi-Square goodness-of-fit test.  
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 
INFORMED CONSENT/ASSENT AND OTHER INFORMATIONAL 
DOCUMENTS PROVIDED TO PARTICIPANTS 
 

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Informed Consent forms describing in detail the study intervention, study procedures, and risks 
are given to the participant and written documentation of informed consent is required prior to 
starting intervention/administering study intervention.  
 
10.1.1.2 
CONSENT PROCEDURES AND DOCUMENTATION (21 CFR 50) 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Consent forms will be 
Institutional Review Board (IRB) and FDA-approved and the participant will be asked to read 
and review the document. The investigator will explain the research study to the participant and 
answer any questions that may arise. A verbal explanation will be provided in terms suited to 
the participant’s comprehension of the purposes, procedures, and potential risks of the study 
and of their rights as research participants. Participants will have the opportunity to carefully 
review the written consent form and ask questions prior to signing. The participants should have 
the opportunity to discuss the study with their family or surrogates or think about it prior to 
agreeing to participate. The participant will sign the informed consent document prior to any 
procedures being done specifically for the study. Participants must be informed that participation 
is voluntary and that they may withdraw from the study at any time, without prejudice. A copy of 
the informed consent document will be given to the participants for their records. The informed 
consent process will be conducted and documented in the source document (including the 
date), and the form signed, before the participant undergoes any study-specific procedures. The 
rights and welfare of the participants will be protected by emphasizing to them that the quality of 
their medical care will not be adversely affected if they decline to participate in this study.  
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to the Investigational Device 
Exemption (IDE) sponsor and regulatory authorities. If the study is prematurely terminated or 
suspended, the Principal Investigator (PI), who is also the sponsor for this trial, will promptly 
inform study participants, the Institutional Review Board (IRB), the FDA, and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as applicable, 
and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the DSMB (see section 10.1.6), sponsor, IRB and/or Food and Drug 
Administration (FDA). The FDA will be notified within 30 working days of the completion or 
termination of the investigation and submit a final report to the FDA and IRB within 6 months 
after completion or termination.  
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 

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Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover 
testing of biological samples in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. Abstraction of existing 
data from a patient’s medical chart during prescreening will be done under an IRB approved 
HIPAA waiver.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the 
Institutional Review Board (IRB), regulatory agencies or pharmaceutical company supplying 
study product may inspect all documents and records required to be maintained by the 
investigator, including but not limited to, medical records (office, clinic, or hospital) and 
pharmacy records for the participants in this study. The clinical study site will permit access to 
such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB, Institutional policies, or sponsor 
requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at the Johns Hopkins University, Division of Brain 
Injury Outcomes (an academic research organization). This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will be 
identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and by Johns Hopkins University research staff will be secured 
and password protected. At the end of the study, all study databases will be de-identified and 
archived at the Johns Hopkins University. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Data collected for this study will be analyzed and stored at the Johns Hopkins University. After 
the study is completed, the de-identified, archived data will be transmitted to and stored at the 
Johns Hopkins University, for use by other researchers including those outside of the study. 
Permission to transmit data to the Johns Hopkins University will be included in the informed 
consent.  
 
When the study is completed, access to study data will be provided through the Johns Hopkins 
University. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Medical Monitor (TBD) 
Clifford Weiss, MD 
Professor, Interventional Radiology 
Name, degree, title 
Johns Hopkins University 
Institution Name  
1800 Orleans Street,  
Address 

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Zayed Towers 7203 
(410) 614-1046 
Phone Number 
cweiss@jhmi.edu 
Email 
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) 
composed of individuals with the appropriate expertise, including a gastroenterologist, bariatric 
surgeon, endocrinologist, and an interventional radiologist.  
 
Members of the DSMB will be independent from the study conduct and free of conflict of 
interest, with measures in place to minimize perceived conflict of interest. The DSMB will meet 
at least semi-annually to assess safety data on each arm of the study. The DMSB will operate 
under the rules of an approved charter that will be written and reviewed at the organizational 
meeting of the DSMB. At this time, each data element that the DSMB needs to assess will be 
clearly defined. The DSMB will provide its input to the IDE Sponsor. 
 
The DSMB will meet initially to set up and review protocol, after first 5 (non-randomized) 
participants have been embolized, after the first 20 randomized participants have undergone 
embolization or sham, and after the first 40 participants have undergone embolization or sham 
and after all 59 participants have undergone embolization or sham. The last DSMB meeting will 
occur 6 months after the last participant has been embolized, in addition to any meetings 
regarding any specific event. In addition, study reports on device/procedure related 
complications will be sent to the DSMB and FDA following treatment of the ten (10 ) pilot 
patients and then after every 10 additional subjects are randomized and treated (blinded). All 
meetings will be documented and any problems regarding the study protocol will be immediately 
relayed to the IRB and FDA. The principal investigator will be responsible for communicating all 
reports and events to the IRB.   
 
10.1.7 CLINICAL MONITORING 
 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the 
conduct of the trial is in compliance with the currently approved protocol/amendment(s), with 
International Council for Harmonisation Good Clinical Practice (ICH GCP), and with applicable 
regulatory requirement(s).  
 
• 
Monitoring for this study will be performed by an independent academic research 
organization (ARO; Johns Hopkins University, Division of Brain Injury Outcomes, 
Baltimore, MD.  
• 
Remote, risk-based, monitoring will be employed for 100% data verification of endpoint, 
safety and other key data variables. On-site monitoring visits will be employed early, for 
initial assessment and training and then for-cause as needed. 
• 
The investigator and IDE Sponsor will be provided copies of monitoring reports within 7 
days of visit. 
• 
Details of clinical site monitoring are documented in a Clinical Monitoring Plan (CMP). 
The CMP describes in detail who will conduct the monitoring, at what frequency 
monitoring will be done, at what level of detail monitoring will be performed, and the 
distribution of monitoring reports. 
 

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10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Each clinical site will perform internal quality management of study conduct, data and biological 
specimen collection, documentation and completion.  An individualized quality management 
plan will be developed to describe a site’s quality management. 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the 
clinical trial is conducted and data are generated and biological specimens are collected, 
documented (recorded), and reported in compliance with the protocol, International Council on 
Harmonisation Good Clinical Practice (ICH GCP), and applicable regulatory requirements (e.g., 
Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).  
 
The investigational site will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and 
inspection by local and regulatory authorities. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data.   
 
Hardcopies of study visit worksheets will be provided for use as source document worksheets 
for recording data for each participant enrolled in the study. Data recorded in the electronic case 
report form (eCRF) derived from source documents should be consistent with the data recorded 
on the source documents.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse 
reactions data) and clinical laboratory data will be entered into the VISION EDC system 
(Prelude Dynamics, Austin, TX), a 21 CFR Part 11-compliant data capture system provided by 
the Data Coordinating Center (Brain Injury Outcomes (BIOS) Division of Johns Hopkins 
University). The data system includes password protection and internal quality checks, such as 
automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. 
Clinical data will be entered directly from the source documents. 
 
10.1.9.2 
STUDY RECORDS RETENTION  
 
Study documents should be retained for a minimum of 2 years after the last approval of a 
marketing application in an International Council on Harmonisation (ICH) region and until there 
are no pending or contemplated marketing applications in an ICH region or until at least 2 years 
have elapsed since the formal discontinuation of clinical development of the study intervention. 

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No records will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the sponsor to inform the investigator when these documents no longer need to 
be retained. 
 
10.1.10 
PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol, International Council on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, 
or the study site staff. As a result of deviations, corrective actions are to be developed by the 
site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 7 working days of identification of the protocol deviation, or within 7 working 
days of the scheduled protocol-required activity. All deviations must be addressed in study 
source documents and reported to the Data Coordinating Center via entry into the eCRF. 
Protocol deviations must be sent to the reviewing Institutional Review Board (IRB) per their 
policies. The site investigator is responsible for knowing and adhering to the reviewing IRB 
requirements. Further details about the handling of protocol deviations will be included in the 
MOP. 
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY 
 
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations: 
 
The funder (Biocompatibles UK Ltd.) will review the primary results manuscript prior to 
publication.  
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical. Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who 
have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial. The study 
leadership has established policies and procedures for all study group members to disclose all 
conflicts of interest and will establish a mechanism for the management of all reported dualities 
of interest. 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
None. 
 

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10.3 ABBREVIATIONS 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
ASA 
American Surgical Association 
ASAT 
Abdominal Subcutaneous Adipose Tissue 
BAE 
Bariatric Embolization 
BEATLES 
Bariatric Embolization of ArTeries with imaging visible EmbolicS 
BES 
Binge Eating Scale 
BIS/BAS 
Behavioral Avoidance/Inhibition Scales 
BMI 
Body Mass Index 
BP 
Blood Pressure 
CBCT 
Cone Beam Computed Tomography 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
CO2 
Carbon Dioxide 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CT 
Computed Tomography 
CTA 
Computed Tomography Angiogram 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DNA 
Genetic Material 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
EGD 
Esophagogastroduodenoscopy 
EUC 
Electrolytes Urea and Creatinine 
EWL 
Excess Weight Loss 
FCI 
Food-Craving Inventory 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GERD 
Gastroesophageal Reflux Disease 
GHS 
Growth Hormone Secretagogue 
GHS-R 
Growth Hormone Secretagogue Receptor 
GI 
Gastrointestinal 
GLP 
Good Laboratory Practices 
GLP-1 
Glucagon-Like Peptide 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HEENT 
Head, Ears, Eyes, Nose, Throat 
HIPAA 
Health Insurance Portability and Accountability Act  
HR 
Heart Rate 
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IMAT 
Intramuscular Adipose Tissue 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 

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ITT 
Intention-To-Treat 
IWQOL 
Impact of Weight on Quality of Life 
LB 
Pounds 
LEAP2 
Liver-Expressed Antimicrobial Peptide 2 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MES 
Medical Effect Score 
MITT 
Modified Intention to Treat 
MOP 
Manual of Procedures 
MRI 
Magnetic Resonance Imaging 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
NSAID 
Nonsteroidal Anti-Inflammatory Drugs 
NTE 
Non Target Vascular Embolization 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PYY 
Peptide YY 
QA 
Quality Assurance 
QC 
Quality Control 
QOL 
Quality of Life 
RYGBP 
Roux-en-Y Gastric Bypass 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
T 
Temperature 
TAT 
Total Adipose Tissue 
TFEQ 
Three-Factor Eating Questionnaire 
TLT 
Total Lean Tissue 
UP 
Unanticipated Problem 
US 
United States 
VAT 
Visceral Adipose Tissue 
 
10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, 
including a description of the change and rationale. A Summary of Changes table for the current 
amendment is located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix A: Post-Procedure Diet Plan (1 week) 
 
Clear liquid diet (1-2 days) 
 
A clear liquid diet consists of clear liquids — such as water, broth and plain gelatin — that are easily 
digested and leave no undigested residue in your intestinal tract.  
Clear liquids and foods may be colored so long as you are able to see through them. Foods can be 
considered liquid if they are even partly liquid at room temperature. You can't eat solid food while on a 
clear liquid diet. 
 
The following foods are allowed in a clear liquid diet: 
 
• 
Water (plain, carbonated or flavored) 
• 
Fruit juices without pulp, such as apple 
or white grape 
• 
Fruit-flavored beverages, such as fruit 
punch or lemonade 
• 
Carbonated drinks, including dark sodas 
(cola and root beer) 
• 
Gelatin 
• 
Tea or coffee without milk or cream 
• 
Strained tomato or vegetable juice 
• 
Sports drinks 
• 
Clear, fat-free broth (bouillon or 
consomme) 
• 
Honey or sugar 
• 
Hard candy, such as lemon drops or 
peppermint rounds 
• 
Ice pops without milk, bits of fruit, seeds 
or nuts 
 
Any foods not on the above list should be avoided. 
 
Once you can tolerate your clear liquid diet – you may progress to a: 
 
Full liquid diet (1-2 days) 
 
A full liquid diet is similar to a clear liquid diet, but you can also consume milk, vegetable juice, pureed 
soups and strained cooked cereals thinned with milk or water. Artificial sweeteners and liquid sweeteners 
are also allowed on a full liquid diet. 
 
Foods Allowed on the Full Liquid Diet 
 
• 
All kinds of fruits and vegetable juice 
• 
Pureed fruit or vegetables 
• 
Milk 
• 
Soy or almond milk 
• 
Yogurt (without fruit chunks) 
• 
Melted cheese 
• 
Eggs can be eaten as a soft custard 
• 
Honey 
• 
Syrup 
• 
Coffee 
• 
Tea 
• 
Soft drinks 
• 
Sports drinks 
• 
Water 
• 
Strained cooked cereal 
• 
Broth 
• 
Creamed soup (no pieces or chunks of 
vegetables or meats) 
• 
Pureed meat can be added to soup 
(again, no chunks) 
• 
Sugar 
• 
Flavored gelatin 
• 
Ice cream (no fruit, chocolate chips, 
etc.) 
• 
Sorbet and frozen yogurt 
 
Once you can tolerate your full liquid diet – you may progress to a: 
 
Regular Diet as directed by the Weight Management Center 
 
Once you advance to a regular weight loss diet, please avoid all sugary beverages – substitute with diet 
or sugar-free drinks.  If in doubt – go with water!