The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

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).

Key Inclusion Criteria:

• Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
• Age≥ 21 years old.
• Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment.
• Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
• Patient has provided written informed consent for participation in the randomized study.

Key Exclusion Criteria:

• Currently taking double-dose PPIs (twice daily dosing).
• Hiatal hernia >3cm as determined by endoscopy.
• Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
• Esophagitis Grade C or D (Los Angeles classification).
• Body mass index >35.
• Diagnosed with an esophageal motility disorder LES.
• Esophageal stricture or gross esophageal anatomic abnormalities
• History of/or known Barrett's esophagus.
• Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.