Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 28
- 主要终点
- Gastroesophageal Reflux Disease (GERD) symptom elimination
研究概览
简要总结
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
详细描述
Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.
Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.
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
- •Age 18-75 years
- •GERD for > 1 year
- •History of daily PPIs use for > 6 months
- •Moderate to severe typical or atypical GERD symptoms off PPIs
- •Complete (responders) or partial (nonresponders) symptom control on PPIs
- •Deteriorated gastroesophageal junction (Hill grade II or III)
- •Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing
- •Willingness to undergo pH/impedance testing, if required
- •Willingness to cooperate with the postoperative diet for 6 weeks
- •Availability for follow up visits at 6 months and 12 months
- •Willingly and cognitively signed informed consent
排除标准
- •BMI > 35
- •Incompletely reducible hiatal hernia with residual of > 5 mm
- •Esophagitis grade D
- •Barrett's Esophagus > 2 cm
- •Esophageal ulcer
- •Fixed esophageal stricture or narrowing
- •Portal hypertension and/or varices
- •Active gastro-duodenal ulcer disease
- •Gastric outlet obstruction or stenosis
- •Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment
- •Coagulation disorder
- •History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- •Pregnancy or plans of pregnancy in the next 12 months
- •Enrollment in another device or drug study that may confound the results
研究组 & 干预措施
TIF Procedure
Intervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. .
干预措施: TIF Procedure (Procedure)
结局指标
主要结局
Gastroesophageal Reflux Disease (GERD) symptom elimination
时间窗: 6-month follow-up
GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index).
次要结局
- Esophageal acid exposure(at 6-, 12-, 24- and 36-month follow-up)
- Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination(at 12-, 24- and 36-month follow-up)
- Elimination of Proton Pump Inhibitor (PPI) usage(at 12-, 24- and 36-month follow-up)
- Healing of reflux esophagitis(at 12, 24- and 36-month follow-up)
- Safety outcomes(first 30 days)