A Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Patient Reported Outcomes - Side effects (PROS) evaluation
研究概览
简要总结
This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.
详细描述
This study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of RefluxStop™ compared with standard Nissen fundoplication for the treatment of subjects suffering from GERD.
A randomization will be performed where the Subjects will be blinded as to assigned randomization group.
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
- •Willing and able to provide informed consent and to participate in the clinical investigation;
- •Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
- •Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;
- •24-hour 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 time during a 24-hour monitoring);
- •Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator
排除标准
- •> 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;
- •Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI <300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP>15mmHg). Hypercontractability defined as DCI >8'000 or pressure >45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;
- •History of bariatric or anti-reflux surgery;
- •Female subjects 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 clinical investigation procedure (as outlined in the IFU);
- •Subjects that are unable to comply with the clinical investigation 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
Patient Reported Outcomes - Side effects (PROS) evaluation
时间窗: 6 months
Patient Reported Outcomes - Side effects (PROS) evaluation at 6 months, combining the well-established side effects of traditional surgical treatment methods: * Dysphagia - swallowing difficulties; * Odynophagia - pain at swallowing; * Inability to belch and inability to vomit; and * Worsening of gas bloating compared to baseline;
次要结局
未报告次要终点