NCT01110811
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- EndoGastric Solutions
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Proportion of patients in clinical remission
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-80 years
- •On daily PPIs for \> 6 months
- •Documented PPI dependency
- •Persistent GERD symptoms without PPI therapy during the titration phase of the study
- •Evidence of two or more of the following while off PPI therapy (\> 10 days):
- •Erosive esophagitis (Los Angeles grade A-C)
- •Abnormal ambulatory pH study
- •Moderate to severe GERD symptoms
- •Normal or near normal esophageal motility (by manometry)
- •Patient willing to cooperate with post-operative dietary recommendations and assessment tests
Exclusion Criteria
- •BMI \> 35
- •Hiatal hernia \> 3 cm
- •Esophagitis LA grade D
- •Esophageal ulcer
- •Esophageal stricture
- •Barretts esophagus (Prague: C\>1, M\>2)
- •Esophageal motility disorder
- •Severe gastric paralysis
- •Pregnancy or plans for pregnancy in the next 12 months
- •Immunosuppression
Outcomes
Primary Outcomes
Proportion of patients in clinical remission
Time Frame: at 6 month follow-up
Fifty nine per cent of patients remained in clinical remission
Secondary Outcomes
- Reduction in symptoms(at 6 moths follow-up)
- Normalized esophageal acid exposure(at 6 months follow-up)
- Healed reflux esophagitis(at 6 months follow-up)
Study Sites (4)
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