GERD Gastroesophageal Reflux Disease Clinical Trial
Official title:
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
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).
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