Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Primary safety endpoint
研究概览
简要总结
Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.
The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.
详细描述
The study plan will include a screening/baseline visit, a surgical procedure phase with hospital stay until discharge, and study visits at 6 weeks, 3 months and 6 months after device implantation.
A follow-up will be performed annually from years 1-5 to evaluate long-term safety and performance with the intention to collect post-market long-term data using the GERD-HRQL score as a screening tool. Data of subjects who agreed to participate in the long-term safety and performance will be analysed after 1, 2, 3, 4 and 5 years.
At the screening/baseline visit, after signing the informed consent, the eligibility of subjects to receive treatment with the study device will be determined. Eligible subjects will then undergo the device implant procedure.
A standard laparoscopic approach will be used to reposition the lower esophageal sphincter (LES) to its intra-abdominal position. The RefluxStop™ device will then be positioned and fixed in the gastric fundus to ensure intra-abdominal positioning of the GEJ at all time. After confirming proper placement, the laparoscopic implant procedure will be completed and access points will be closed. The procedure will be recorded and saved only with study identification number and without subject ID information. The same applies for images on contrast swallow controlling the device.
Evaluations will be performed daily during hospitalisation and in an additional 3 study visits in the outpatient setting at 6 weeks, 3 months and 6 months. Subjects who have given their consent to participate in the long-term safety and performance follow-up part of the study will be followed annually from year 1-5.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's age >= 18 years and <= 75 years
- •Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate
- •Subject is willing and able to participate
- •Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events
- •Subject has documented typical GERD symptoms present for > 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain
- •Subject requires daily PPI anti GERD medication
- •Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal esophageal pH must be <= 4 for >= 4.5% if time during a 24-hour monitoring
排除标准
- •Subject is currently participating in another study involving investigational drugs or devices
- •Subject has a history of gastro esophageal surgery, anti-reflux or bariatric procedure
- •Subject has a history of endoscopic anti-reflux intervention
- •Subject has a history or a suspicion of esophageal or gastric cancer
- •Subject has a history of major psychiatric disorder
- •Presence of a para-esophageal hernia or sliding hernia of > 3cm determined on endoscopy
- •Presence of an esophagitis grade C or D according to the Los Angeles classification
- •Presence of esophageal dysmotility disorder such as but not limited to scleroderma, achalasia, Nutcracker oesophagus
- •Presence of esophageal stricture or stenosis
- •Presence of delayed gastric emptying
- •Presence of esophageal or gastric varies
- •Subject has a body mass index (BMI) > 35kg/m2
- •Female subjects who are pregnant or nursing
- •Known sensitivity or allergies to silicone materials
- •Subjects who are unable to comply with the protocol requirements
- •Subjects with limited life expectancy (< 3 years)
- •Intra-operative findings that may preclude conduct of the study procedures
结局指标
主要结局
Primary safety endpoint
时间窗: at 6 months
Assessment of incidence of serious adverse device effects (SADEs) and procedure-related serious adverse events (SAEs)
Primary efficacy endpoint
时间窗: at 6 months
Percent reduction from baseline of GERD symptoms based on the GERD-HRQL score (questions 1-10). The data will also be presented as the number of subjects obtaining a 50% improvement of the baseline figures, with success defined as 60% of the subjects to reach such score improvement. Thus, the aim of this analysis is to show that the lower limit of the confidence interval exceeds 60%.
次要结局
- Secondary efficacy endpoint: Endoscopy(measured at baseline, 6 months and if therapy failure)
- Secondary efficacy endpoint: HRQL all other timepoints(measured at baseline, 6 weeks, 3 months and follow-up years 1-5)
- Secondary efficacy endpoint: Foregut(measured at baseline, 6 weeks, 3 months, 6 months and follow up years 1-5)
- Secondary efficacy endpoint: additional questions(measured at baseline, 6 weeks, 3 months, 6 months and follow up years 1-5)
- Secondary efficacy endpoint: 24-hr pH monitoring(measured at baseline, 6 months, 5 years and if therapy failure)
- Secondary efficacy endpoint: PPI usage(measured at baseline, 6 weeks, 3 months, 6 months and follow up years 1-5)
- Secondary safety endpoint(at 6 weeks, 3 months, 6 months (ADEs and AEs only) and annually years 1-5)
- Secondary efficacy endpoint: device location(measured at hospital stay, 6 weeks, 6 months, 5 years and if therapy failure)