NCT07004439尚未招募不适用
A Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
Implantica CE Reflux Ltd.5 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Reduction of Patient Reported Outcome - Side effects (PROS)
研究概览
简要总结
A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD.
Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.
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
- 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;
- •Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
- •Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
- •24-hour pH or impedance pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be < 4 for ≥ 4.5% of total time during a 24-hour monitoring) and/or total reflux episodes >55 or weekly acid >26 for > 5 seconds, all measured 5 cm above LES);
- •Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.
排除标准
- •Hiatal Hernia larger than 8 cm;
- •Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
- •History of bariatric surgery wherein the stomach fundus has been extirpated;
- •Female subjects who are pregnant;
- •Known sensitivity or allergies to silicone materials;
- •Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
- •Subjects that are unable to comply with the registry requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement).
结局指标
主要结局
Reduction of Patient Reported Outcome - Side effects (PROS)
时间窗: 1 year
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
次要结局
- Incidence of safety events(3 and 6 months and years 1 to 7)
- Reduction of Patient Reported Outcome - Side effects (PROS)(6 months and years 2 to 7)
研究者
研究点 (5)
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