NCT00200044终止不适用
Gatekeeper® System Sham-Controlled Study for the Treatment of GERD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 143
- 试验地点
- 11
- 主要终点
- Reduction in serious device and procedure related adverse device effects.
研究概览
简要总结
The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease.
详细描述
The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease
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 —（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
Reduction in serious device and procedure related adverse device effects.
时间窗: 6 months
次要结局
- Improvement in espophageal pH(6 months)
研究者
研究点 (11)
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