a study of bioenterics® intragastric balloon (bib®) system to assist in the weight management of obese subjects

Conditions: Obesity

Summary: 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.


Eligibility criteria:
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)