NCT05870163招募中不适用
A Post-market Registry Study to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
Implantica CE Reflux Ltd.6 个研究点 分布在 4 个国家目标入组 2,500 人开始时间: 2023年2月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 6
- 主要终点
- Primary safety endpoint
研究概览
简要总结
This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent and to participate in the registry study,
- •Patient's age ≥ 18 years or according to local legal age of adulthood if older,
- •Documented GERD present for > 6 months,
- •Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be <4 for >4.5% of time during a 24-hour monitoring and/or total reflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)
- •Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.
- •Exclusion criteria:
- •Presence of para-esophageal hernia or sliding hernia > 3 centimeters,
- •Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
- •History of bariatric surgery wherein the stomach fundus has been extirpated,
- •Female patients who are pregnant or nursing,
- •Known sensitivity or allergies to silicone materials,
- •Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
- •Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).
排除标准
- 未提供
结局指标
主要结局
Primary safety endpoint
时间窗: 6 months
Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)
Primary performance endpoint
时间窗: 6 months
Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms)
次要结局
- Secondary performance endpoints: hernia assessment(6 months)
- Secondary performance endpoints: pH monitoring(6 months)
- Secondary safety endpoint(3 and 6 months and annually up to 5 years)
- Secondary performance endpoints: RefluxStop device position(6 months)
- Secondary performance endpoints(3 months and annually up to 5 years)
研究者
研究点 (6)
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