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

Torax Medical

Status and phase: Completed; Phase 4

Conditions: GERD Gastroesophageal Reflux Disease

Treatments: Drug: Omeprazole; Device: LINX Reflux Management System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02505945

4959

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 152 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
2. Age≥ 21 years old.
3. 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.
4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
5. Patient has provided written informed consent for participation in the randomized study.

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\]

Treatment:

Drug: Omeprazole

Treatment Arm

Active Comparator group

Description:

LINX Reflux Management System

Treatment:

Device: LINX Reflux Management System