Gatekeeper® System Sham-Controlled Study for the Treatment of GERD
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
- •Diagnosis and main criteria for inclusion:
- •Subjects diagnosed with GERD with symptomatic improvement on PPIs.
- •Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.
- •Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI.
- •Diagnosis and main criteria for
排除标准
- •Extensive Barrett's Esophagus (> 2 cm).
- •Esophagitis (LA Classification Grades C or D).
- •Previous history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer.
- •Large hiatal hernia (> 3 cm).
- •Current complaints of clinical dysphagia evidenced by greater than one occurrence per month.
- •Esophageal strictures
- •Esophageal or gastric varices
研究组 & 干预措施
Sham
This arm of the study has the procedure but does not get the Gatekeeper prostheses. The Sham arm has the option to cross-over to the Treatment arm at the 6-month visit.
干预措施: Gatekeeper Reflux Repair System (Device)
Treatment
The treatment arm has the Gatekeeper devices implanted.
干预措施: Gatekeeper Reflux Repair System (Device)
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)