Clinical Trial: Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study
Brief Summary: The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
Detailed Summary:
Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).
Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.
Sponsor: EndoGastric Solutions
Current Primary Outcome: Proportion of patients in clinical remission [ Time Frame: at 6 month follow-up ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reduction in symptoms [ Time Frame: at 6 moths follow-up ]
- Normalized esophageal acid exposure [ Time Frame: at 6 months follow-up ]
- Healed reflux esophagitis [ Time Frame: at 6 months follow-up ]
Original Secondary Outcome: Same as current
Information By: EndoGastric Solutions
Dates:
Date Received: April 23, 2010
Date Started: April 2010
Date Completion: March 2017
Last Updated: August 11, 2016
Last Verified: August 2016
