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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
278
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.
Mt. Graham Regional Medical Center
Safford, Arizona, United States
Tempe St. Luke's Hospital
Tempe, Arizona, United States
Swedish Medical Center and SurgOne P.C.
Gastroesophageal Reflux Disease (GERD) symptom elimination
GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index).
Time frame: 6-month follow-up
Elimination of Proton Pump Inhibitor (PPI) usage
Elimination of Proton Pump Inhibitor (PPI) usage
Time frame: at 12-, 24- and 36-month follow-up
Esophageal acid exposure
Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH \< 4.
Time frame: at 6-, 12-, 24- and 36-month follow-up
Healing of reflux esophagitis
Healing of reflux esophagitis
Time frame: at 12, 24- and 36-month follow-up
Safety outcomes
Incidence of anticipated and unanticipated adverse events
Time frame: first 30 days
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
Time frame: at 12-, 24- and 36-month follow-up
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