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

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.