NCT02413567已完成不适用
Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
研究概览
简要总结
The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 75 Years（Adult, Older 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
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
时间窗: 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
时间窗: 24 weeks post-procedure
次要结局
未报告次要终点
研究者
研究点 (12)
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