Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 208
- 试验地点
- 17
- 主要终点
- Percentage of Excess Weight Loss (EWL)
研究概览
简要总结
Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction.
Up to 200 participants at 9 locations in the United States will participate in this study.
The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Excess Weight Loss (EWL)
时间窗: 12 months
Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²)
次要结局
- Number of Participants With ≥25% EWL(12 months)
- Change in Blood Pressure for ESG Intervention From Baseline to 24 Months(Baseline, 24 months)
- Number of Participants Off or With Reduction in Diabetes Medications(12 months)
- Change in HgbA1c(Baseline, 12 months)
- Change in HgbA1c for ESG Intervention From Baseline to 24 Months(Baseline, 24 months)
- Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)(Baseline, 12 months)
- Number of Participants With Major Depression or Severe Major Depression at 12 Months(12 months)
- Change in Eating Behaviors(Baseline, 12 months)
- Number of Participants Off Or With Reduction in Antihypertensive Medications(12 months)
- Change in Blood Pressure(Baseline, 12 months)
- Percentage of Total Body Weight Loss (TBWL)(12 months)
- Number of Participants to Achieve ≥5% TBWL(12 months)
- Changes in Health Status Survey Scores(Baseline, 12 months)
- Number of Participants to Achieve ≥10% TBWL(12 months)
- Esophagitis at Repeat Endoscopy(12 months)
- Number of Participants With Major Depression or Severe Major Depression at Baseline(Baseline)
研究者
Barham K. Abu Dayyeh, M.D.
Barham Abu Dayyeh, Principal Investigator
Mayo Clinic