The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. The study device is designed to occupy space within the stomach and induce satiety. After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (with endoscopic placement of study device) or the control group (no placement of study device) on an unblinded basis. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48 week study duration.

Official Title
-----------------
IDE G090121 A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Intragastric Balloon (RIBTM) in Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: ReShape Intragastric Balloon
* Other: Control Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged ≥ 20 years and ≤ 60 years; At screening, body mass index (BMI) ≥ 30 Kg/m^2 and ≤ 40 Kg/m^2; Have a history of obesity (BMI ≥ 30 kg/m^2) for at least 6 months and have failed other weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs; Subject is willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet; Subject has reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 24 weeks); At screening, total Beck Depression Inventory (BDI) score < 12 points, and BDI affective subscale score < 7 points. Subject is able to follow requirements outlined in the protocol, including complying with the visit schedule, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, electrocardiography (ECG), and/or clinical laboratory testing; Subject is willing to take prescribed proton pump inhibitors (PPIs); Subject is able to provide written informed consent; If female of child-bearing potential, the subject is willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study. Exclusion Criteria: Participating in an organized weight loss program (e.g., Weight Watchers); Parkinson's disease; Chronic narcotic use; Clinically relevant abdominal adhesions (e.g., history of bowel obstruction); History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy and cholecystectomy), obstruction, and/or adhesive peritonitis; History or symptoms of clinically significant esophageal or GI motility disorders; A hormonal or genetic cause for subject's obesity; A history of myocardial infarction in the previous 6 months, current New York Heart Association (NYHA) Functional Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation); History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease; History or symptoms of inflammatory bowel disease, such as Crohn's disease; History or symptoms of uncontrolled or unstable thyroid disease; Subjects with a positive breath test for Helicobacter pylori at screening; History or symptoms in the past 12 months of significant irritable bowel disease, peritonitis, active esophagitis, gastric or duodenal ulceration, or GI bleeding; History of esophageal and/or stomach cancer. Type I diabetes; Placement of previous intragastric balloon or similar device with associated adverse; or any endogastric procedure within the last 6 months; Ongoing treatment with anticoagulants, steroids, aspirin (> 81 mg/day), non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants or to reduce GI motility, and unwillingness to discontinue the use of these concomitant medications; Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study; Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia; Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential); Known allergy to silicone; A history of anemia Participation in another investigational trial within 1 month of screening or planned enrollment during the study period. Presence of peptic ulcerations, hiatal hernia (> 2 cm), patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus or other findings deemed exclusionary in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReShape Intragastric Balloon<br>Patients receiving the ReShape Intragastric Balloon | Device: ReShape Intragastric Balloon<br>* Placement of ReShape Medical Intragastric Balloon for twenty four weeks<br>|
| Other: Control Arm<br>Weight loss using behavior modification (diet and exercise counseling) alone | Other: Control Arm<br>* Behavioral Modification (Diet and exercise counseling) alone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %Excess Weight Loss | the difference between the %EWL between treatment and control groups must be clinically significant | 36 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With >=25% Excess Weight Loss (EWL) | a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months | 12 months |