NCT00200083已完成不适用
SHAPE: Screened Health Assessment & Pacer Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 10
- 主要终点
- Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
研究概览
简要总结
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
详细描述
The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.
SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •18 to 65 years of age at time of screening
- •BMI of 35 to 55 kg/m2 at time of screening
- •Patients with a reported history of five years of obesity (BMI > 30 kg/m2)
排除标准
- •Patients who are excluded by the screening algorithm
- •Patients scoring 29 or higher on the Binge Eating Scale Questionnaire
- •Patients taking any weight loss medication or other drugs that can affect body weight
结局指标
主要结局
Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
时间窗: Baseline, 12 months
次要结局
- Percentage change in body weight and BMI from baseline at each study visit(Baseline and each study visit)
- Change from baseline in levels of satiety and appetite at each study visit.(Baseline and each study visit)
- Time to loss of weight maintenance or "relapse of weight loss"(Baseline and each study visit)
- Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments(During the course of the study until termination.)
- Percent excess weight loss (% EWL) from baseline at each study visit(Baseline and each study visit)
- Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization(Baseline and 12 months.)
- Proportion of subjects who lose ≥ 5% in body weight from baseline through Month 9, and maintain the weight loss for at least 3 months (i.e., through 12 months from randomization)(Baseline and each study visit.)
研究者
研究点 (10)
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