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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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GERD Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Omeprazole
* Device: LINX Reflux Management System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Double-dose PPI [Omeprazole 20 mg BID (twice a day)] | Drug: Omeprazole<br> <br> * Other names: Prilosec;|
| Active Comparator: Treatment Arm<br>LINX Reflux Management System | Device: LINX Reflux Management System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Reflux, Gastric Acid Reflux Disease, Heartburn