EndoStim Patient Registry-LES Stimulation System for the Treatment of GERD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 350
- 试验地点
- 34
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
To provide a research tool enabling physicians to monitor long term clinical outcomes for patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES Stimulation System.
详细描述
The EndoStim Patient Registry provides a framework for data collection on patients with GERD treated with the EndoStim LES Stimulation System. The primary objective is to provide a tool for participating physician investigators to collect and analyze outcomes data related to the use of the EndoStim LES Stimulation System.
This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms paper or on-line.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject meets therapy indications
- •Subject signs informed consent
- •Subject has a planned EndoStim LES Stimulation System implant (prospective) OR subject has already had EndoStim LES Stimulation System implant (retrospective)
排除标准
- •1. Subject meets therapy contraindications
结局指标
主要结局
Incidence and severity of adverse events
时间窗: 5 years post-implant
Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up
次要结局
- Change in GERD-HRQL(Change in GERD-HRQL questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Comparison of pH values(The pH values of % 24-hour esophageal pH < 4.0, and the number of reflux events > 1 minute and > 5 minutes will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Comparison of symptoms and quality of life(Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Change in antisecretory medication use(The use of antisecretory medication will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Change in Structured GI Questionnaire responses (vs. baseline)(Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Change in sleep related quality of life(Sleep related quality of life will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Change in work productivity impairment(Work productivity will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)
- Change in Reflux Disease Questionnaire (RDQ) scores(RDQ questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years)