Trials / Terminated
TerminatedNCT00857597
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transoral Incisionless Fundoplication | The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference. |
| DRUG | Proton Pump Inhibitors; active control | Proton Pump Inhibitors; active control |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2009-03-06
- Last updated
- 2018-03-30
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00857597. Inclusion in this directory is not an endorsement.