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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Proton Pump Inhibitors; active control
University Hospital Maastricht
Maastricht, Limburg, Netherlands
GERD symptoms
Time frame: Baseline
GERD symptoms
Time frame: 6 month follow-up
GERD symptoms
Time frame: 12 month follow-up
PPI usage
Time frame: at 0, 6 and 12 month follow- up
Lower esophageal acid exposure
Time frame: at 0, 6 and 12 month follow- up
Esophagitis
Percentage of Participants with Esophagitis (Los Angeles classification scale)
Time frame: at 0, 6 and 12 month follow- up
Rate of adverse events
Time frame: at 0, 6 and 12 month follow- up
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