NCT00857597终止3 期
A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- GERD symptoms
研究概览
简要总结
The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
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
- 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
- •Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days)
- •On daily PPIs for > 1 year
- •Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs)
- •Normal or hypotonic LES resting pressure (5-40 mmHg)
- •Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
- •Signed informed consent
排除标准
- •BMI > 35
- •Hiatal hernia > 2 cm
- •Esophagitis grade D
- •Barrett's esophagus
- •Esophageal stricture
- •Esophageal ulcer
- •Esophageal motility disorder
- •Gastric motility disorder
- •Prior splenectomy
- •Gastric paralysis
- •Pregnancy (in females)
- •Immunosuppression
- •Portal hypertension
- •Coagulation disorders
- •Previous antireflux procedure
- •Any other health condition, which the investigator believes would prevent the patient from completing the study
- •Lack of fluency in English
研究组 & 干预措施
EsophyX
Experimental
干预措施: Transoral Incisionless Fundoplication (Procedure)
Proton Pump Inhibitors
Active Comparator
干预措施: Proton Pump Inhibitors; active control (Drug)
结局指标
主要结局
GERD symptoms
时间窗: 12 month follow-up
次要结局
- PPI usage(at 0, 6 and 12 month follow- up)
- Lower esophageal acid exposure(at 0, 6 and 12 month follow- up)
- Esophagitis(at 0, 6 and 12 month follow- up)
- Rate of adverse events(at 0, 6 and 12 month follow- up)
研究者
研究点 (1)
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