Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in People With Obesity
Phase: NA
Conditions: Obesity, Morbid
Sponsor: Endobar Solutions LLC

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
Page 1 of 7 
 
 
 
EndoBar 
 
Study Title: Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in 
People with Obesity 
Sponsor: 
  
 
Endobar Solutions, LLC 
Office Address: 
 
Ramland Road 40 
 
 
 
 
Orangeburg 
 
 
 
 
NY 10962, USA 
 
 
Protocol No:  
 
CZ01 
Product: 
The Endobar Infusion Catheter System  
Investigational Device: 
The Endobar Infusion Catheter System (consisting of an occlusion 
balloon catheter, a Smart Manifold delivery system and 
microspheres)  
Revision Number: 
 
Rev B 
Release Date:  
 
November 17, 2016 
NCT Number: 
 
NCT03185949 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL:  The information in this document is CONFIDENTIAL and PROPRIETARY.  
It may not be provided to any third party, except as outlined in the enclosed documents, without 
the written consent of Endobar LLC. 

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
Page 2 of 7 
 
 
Contact Information 
 
Clinical Contact 
Endobar Solutions, LLC. 
Ramland Road 40 
Orangeburg 
NY 10962, USA 
Nickolas Kipshidze, MD, PhD, DSc 
 
Clinical Representative  
(Czech Republic)  
Stepan Kralovec 
High Tech Med Consult 
Frimlova 1322/4e 
15500 Prague 5 
Czech Republic 
 
Principal Investigator 
Martin Fried, MD 
Co-Principal Investigator Vivek Reddy, MD, Petr Neuzil, MD 
Study Monitor 
Stepan Kralovec 
High Tech Med Consult 
Frimlova 1322/4e 
15500 Prague 5 
Czech Republic 
 
 
 
Clinical Research Site 
 
 
OB KLINIKA a.s. 
Pod Krejcárkem 975 
Praha 3 – Žižkov 
Tel.: +420 255 725 110 
 
 
 
 

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
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Revision History 
Section 
Change 
Reason For Change 
Changes below to version A resulting in version B 
All document 
Document update according EN 
ISO 14155:2011  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
Page 4 of 7 
 
 
 
PROTOCOL SUMMARY 
Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in People with 
Obesity  
 
Study Objective 
To evaluate the efficacy and safety of the Endobar gastric embolization system for the treatment 
of obesity before continuing to a larger Pivotal Trial. 
 
Investigational Device 
The investigational device in this clinical study is the Endobar Infusion Catheter System – a 
disposable system consisting of an occlusion balloon catheter, a Smart Manifold delivery system. 
 
Study Design/Planned Number of Subjects 
This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. 
A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of  
35.0–55.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment 
with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves 
catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and 
Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end 
of 6 months all subjects randomized to the Sham Control group will receive catheter-based 
embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to 
Endobar Therapy groups will be followed for a total of 12 months. 
 
Study Duration 
The duration of the study is expected to last approximately 18 months from the first enrollment. An 
additional 12 months to the study closeout after the last follow-up. 
Sample Size 
This study is powered to detect a differential change in total body weight loss between groups. 
Briefly, 18 patients are required in each group to have an 85% chance of detecting, as significant 
at an alpha of 5%, a change in total body weight loss of 5% in the Control group to 10% in the 
GAE group (assuming a standard deviation of 5%), and 1:1 randomization. Again, assuming a 
10% loss to follow-up, a total of 20 patients are required per group. Secondary endpoints will be 
evaluated using descriptive statistics. 
 
 

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
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Primary Endpoints 
Percent total body weight loss at 6 months and at 12 months are the primary endpoints intended 
to provide efficacy and safety of investigational device. 
• Efficacy Endpoints: The primary efficacy endpoints of the study will be difference in 
percent total body weight loss at 6 months between Sham Control and Endobar Therapy 
groups and percent total body weight loss at 12 months in the group randomized to initial 
Endobar Therapy. Success will be defined as: 1) ≥5%total body weight loss at 6 months 
with statistical superiority to the Sham Control group and 2) ≥5%total body weight loss at 
12 months. 
 
• Safety Endpoints: All participants will be carefully monitored by a physician and 
research nurse during this study.  Safety will be monitored by:  
o Incidence of device-, procedure- and therapy- related adverse events 
o Incidence of device related, or unrelated, serious adverse events, including 
unanticipated adverse device effects 
 
Secondary Endpoints 
The secondary outcomes measured at 6 and 12-months are:  
• Percent excess weight (%EWL), defined as absolute weight loss divided by baseline excess 
weight and multiplied by 100, at 6 months and at 12 months. Excess weight will be 
determined from ideal body weights based on a BMI=25 kg/m2   
• Proportion of subjects who achieve ≥5% and ≥10% total body weight loss from baseline at 
6 months and at 12 months.  
• Percent change in selected coronary heart disease risk factors (plasma triglyceride and 
HDL-cholesterol, and systolic and diastolic blood pressure) at 6 months and at 12 months) 
• Success of performing the radiological procedure 
 
Additional Endpoints of Interest (assessed at baseline and at 6 and 12 months) 
• Changes in mood (depression/anxiety) 
• Change in quality-of-life  
• Change in eating behavior 
• Change in volume of Ensure consumed to achieve satiation 
• Change in plasma ghrelin and glucagon-like peptide 1 concentrations 
• Change in oral glucose tolerance and insulin sensitivity 
 
Key Inclusion Criteria 
• BMI 35.0–50.0 kg/m2 at time of screening 
• 21–60 years of age at time of screening  

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
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• Women of childbearing potential must agree to use at least one form of birth control 
(prescription hormonal contraceptives, diaphragm, IUD, condoms with or without 
spermicide, or voluntary abstinence) from time of study enrollment through study exit.  
• Willing and able to provide informed consent  
 
Key Exclusion Criteria 
• Previous bariatric, gastric pancreatic, hepatic, and/or splenic surgery 
• History of duodenal or gastric ulcers or regularly taking medications (therapy >1 day per 
week) that can cause ulcers (e.g. aspirin, non-steroidal anti-inflammatory drugs)  
• Prior radiation to the upper abdomen 
• Prior embolization to the stomach, spleen or liver 
• Portal venous hypertension 
• Active H. pylori infection 
• Uncontrolled hypertension (> 160/100 with or without medication). 
• Diabetes (determined by medical history, fasting blood glucose or results of an oral glucose 
tolerance test) 
• Serum triglyceride > 400 mg/dL at screening. 
• Class 4 or 5 surgical risk based on standard ASA criteria (Saklad M. Grading of patients 
for surgical procedures. Anesthesiol. 1941; 2:281–4). Need to define these criteria here  
• Severe pulmonary or cardiovascular disease defined as a history or evidence of serious 
cardiovascular disease, including myocardial infarction, acute coronary syndrome, 
coronary revascularization, heart failure requiring medications, history of sudden cardiac 
death, or NYHA (New York Heart Association) class III or IV heart failure (defined 
below):   
o Class III: patients with marked limitation of activity; they are 
comfortable only at rest.  
o Class IV: patients who should be at complete rest, confined to bed 
or chair; any physical activity brings on discomfort and symptoms 
occur at rest. 
• Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5 at 
screening).  
• Anemia (Hb < 10.0 g/dL) at screening. 
• Malignancy in the last 5 years (except for non-melanoma skin cancer). 
• Evidence of other significant organ system dysfunction (e.g. cirrhosis, renal failure)  
• Pregnant or lactating. 
• History of substance abuse in last 3 years. 
• Thyroid Stimulating Hormone (TSH) >2.0 x upper limit of normal at screening.  
• Taking prescription or over-the-counter medications for weight loss in the last 3 months 
before screening, or planning to participate in a commercial weight loss program in the 
next 5 years.  
• Taking diuretic medication for congestive heart failure or edema. 
• Evidence of significant mucosal inflammation, ulceration or ischemia detected on 
endoscopy, and those with unsuitable left gastric anatomy as judged by the study site 
physician will be excluded. 

 
Clinical Protocol Synopsis CZ01 
Revision : B November 17, 2016 
EndoBar Solutions LLC © 2016 
Confidential and Proprietary 
Page 7 of 7 
 
 
• Psychiatric illness that could affect compliance with the study, as judged by the site 
principle investigator. 
• Unable to complete screening requirements (compliance with visits and dietary record)  
• Taking medication once or more per week that causes weight gain (e.g. atypical 
antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, 
tamoxifen, glucocorticoids)  
• Chronic abdominal pain that would potentially complicate management.  
• Unstable weight (>3% change; self-reported) over the previous 2 months at time of 
screening. 
• Subjects whom the site investigator, research team, or the study medical monitor feel is 
not able to participate in the study for any reason, including poor general health or 
unable/unwilling to follow the study protocol. 
 
Follow-up Schedule 
• Screening 
• Baseline visit  
• Interventional Radiology Procedure 
• Randomization  
• Left Gastric Artery Occlusion / Placebo  
• Follow-up Visits Week: 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 26, 28, 32, 36, 40, 44, 52