Official Title
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Phase
Phase 4Lead Sponsor
Torax Medical IncorporatedStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
GERD Gastroesophageal Reflux DiseaseIntervention/Treatment
omeprazole ...Study Participants
152This 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).
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.
| Event Type | Organ System | Event Term | Control Arm | Treatment Arm |
|---|
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.
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.
