A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.

Inclusion Criteria:

• Have a BMI ≥ 30 and ≤ 40;
• Be male or female, between 18 and 65 years of age, inclusive;
• Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
• Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
• Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 26 weeks);
• Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing;
• Must be willing to take prescribed proton pump inhibitors (PPIs)and other medications as prescribed by the investigator;
• Be able to provide written informed consent and authorization for use and release of Health and Research Study Information;
• Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.

Exclusion Criteria:

• Any surgery of the foregut excluding uncomplicated cholecystectomy
• History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy), GI obstruction, adhesive peritonitis, and/or hiatal hernia (>/= 2 cm);
• A patulous pyloric channel;
• History or symptoms of esophageal or GI motility disorders (not just those with <40%) as these patients are particularly susceptible to the development of esophagitis;
• History or previous symptoms of delayed Gastric Emptying (GE) and/or delayed GE having been documented on a previously performed gastric scintigraphy study or another previously performed diagnostic study such as a UGI x-ray series;
• Current symptoms of delayed GE;
• A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);
• Anemia defined as a hemoglobin value for females of <11.3 g/dl and for males < 13.0 g/dl;
• 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 or Ulcerative Colitis;
• History or symptoms of uncontrolled or unstable thyroid disease;
• Subjects with a positive test for Helicobacter pylori (H.p.) at screening; subjects may participate in the study if, prior to randomization, they are treated with a pharmacological regimen designed to eradicate their H.p. and subsequently have a negative H.p. breath test indicating that the H.p. has been eradicated
• History or symptoms in the past 24 months of significant irritable bowel syndrome, peritonitis, active esophagitis, gastritis and/or duodenitis, gastric or duodenal ulceration, GI hemorrhage, or GI bleeding;
• Type I diabetes;
• Placement of previous intragastric balloon or similar device;
• Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastroduodenal mucosal irritants or to reduce GI motility, and/or an 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;
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study;
• Poor general health, presence of a specific condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or placement of the BIB, or may interfere significantly with the subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history within the last 5 years)