NCT00469391已完成2 期
A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss
Morphic Medical Inc.8 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- Percent Excess Weight Loss (%EWL) at Week 12
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
详细描述
This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 35 with a significant comorbid condition or BMI 40-60
- •Candidate for Bariatric Surgery
排除标准
- •No pathologies of the GI Tract
- •No anti-coagulant or non-steroidal anti-inflammatory medications
结局指标
主要结局
Percent Excess Weight Loss (%EWL) at Week 12
时间窗: 3 months
Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
A Multicenter Study for Pre-Surgical Weight LossObesityNCT00830440Morphic Medical Inc.43
已完成
2 期
Study for Pre-Surgical Weight Loss in Type II Diabetes PatientsObesityType 2 DiabetesNCT00791128Morphic Medical Inc.22
已完成
不适用
Safety and Efficacy Study of Duet TRSRoux En Y Gastric BypassNCT00950872Medtronic - MITG29
已完成
不适用
Seal-G / Seal-G MIST StudyGastrointestinal CancerColon CancerNCT04532515Advanced Medical Solutions Ltd.160
已完成
2 期
Study for Short Term Weight Loss in Candidates for Bariatric SurgeryObesityNCT00985491Morphic Medical Inc.46