NCT00730327已完成不适用
Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- Mean Percent Excess Weight Loss (%EWL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Mean Percent Excess Weight Loss (%EWL)
时间窗: 9 months
The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.
Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group
时间窗: 9 months
The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) \* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.
次要结局
- Percent of Participants With Comorbid Conditions(Baseline, Week 26, Week 39, Week 52)
- Change in Quality of Life (SF-36)(Baseline, Week 39)
- Change in Quality of Life (IWQOL-Lite)(Baseline, Week 26, Week 39, Week 52)
- Change in Participant Depression (Beck Depression Inventory II)(Baseline, Week 26, Week 39, Week 52)
研究者
研究点 (2)
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