This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).
Prospective, multicenter, 2:1 randomized, cross-over, two arms * Control arm: Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\] * Treatment arm: LINX Reflux Management System Up to 20 study centers throughout the U.S. will participate. Approximately150 patients will be enrolled into the study. Subjects will be randomized 2:1 into the double-dose PPIs arm (100 subjects) and the LINX arm (50 subjects).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
University of South Alabama
Mobile, Alabama, United States
Elimination of Moderate-severe Regurgitation at 6 Months
The primary endpoint was the percent of patients in both treatment arms who achieved elimination of moderate-severe regurgitation at 6 months, as reported on the foregut symptom questionnaire.
Time frame: 6 months
Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores
Successful Reduction at 6 months (≥50% reduction in total) Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores from Baseline PPI On medication GERD HRQL scores.
Time frame: 6 months
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