Gastroesophageal Reflux Disease Clinical Trial
Official title:
Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to
each question) or clinically significant improvement (≥ 50% reduction in total scores) at
6-month follow-up compared to baseline.
Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant
improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete
discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in
reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported
by low incidence of serious adverse events.
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