A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 18
- 主要终点
- Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,
研究概览
简要总结
The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.
详细描述
Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).
Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.
Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Dependent upon daily PPIs for > 6 months
- •Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent.
- •Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.
- •Abnormal ambulatory pH study off PPI therapy for 7 days.
- •Normal or near normal esophageal motility (by manometry)
- •Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm
- •Patient willing to cooperate with post-operative dietary recommendations and assessment tests
- •Signed informed consent
排除标准
- •BMI > 35
- •Hiatal hernia > 2 cm
- •Esophagitis Los Angeles grade C or D
- •Esophageal ulcer
- •Esophageal stricture
- •Esophageal motility disorder
- •Pregnancy or plans for pregnancy in the next 12 months (in females)
- •Immunosuppression
- •Portal hypertension and/or varices
- •History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- •Active gastro-duodenal ulcer disease
- •Gastric outlet obstruction or stenosis
- •Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
- •Coagulation disorders
- •Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.
结局指标
主要结局
Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,
时间窗: 6 month follow up
Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.
次要结局
- Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score(6 months post procedure)