Trials / Completed
CompletedNCT01110811
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- EndoGastric Solutions · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transoral Incisionless Fundoplication (TIF) | The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2015-09-01
- Completion
- 2018-12-01
- First posted
- 2010-04-27
- Last updated
- 2019-03-06
Locations
4 sites across 3 countries: Belgium, France, Sweden
Source: ClinicalTrials.gov record NCT01110811. Inclusion in this directory is not an endorsement.