A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 16
- 主要终点
- Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
研究概览
简要总结
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
时间窗: Week 24
An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Treatment Group Responder Rate Dichotomized at 25% EWL
时间窗: 24 weeks
An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%.
次要结局
- Weight Loss Maintenance Six Months Following Device Removal(48 weeks)