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

Phase 4

Completed

• Conditions: GERD Gastroesophageal Reflux Disease
• Interventions: Device: LINX Reflux Management System; Drug: Omeprazole

• Registration Number: NCT02505945
• Lead Sponsor: Torax Medical Incorporated

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Primary Completion: 2017-10
• Study Completion: 2018-08
• Results First Submitted: 2018-11-15
• Results First Submitted QC: 2018-11-15
• Status Verified: 2018-12
• Results First Posted: 2018-12-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Arm	LINX Reflux Management System	LINX Reflux Management System
Control Arm	Omeprazole	Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\]

Primary Outcome Measures

Name	Time	Method
Elimination of Moderate-severe Regurgitation at 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores	6 months	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.

Trial Locations

Locations (21)

Albert Einstein Healthcare Network; 🇺🇸 Philadelphia, Pennsylvania, United States

SurgOne Foregut Institute; 🇺🇸 Englewood, Colorado, United States

UCSD; 🇺🇸 San Diego, California, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Bapist Health; 🇺🇸 Heber Springs, Arkansas, United States

Albany Surgical PC; 🇺🇸 Albany, Georgia, United States

St. Elizabeth Healthcare; 🇺🇸 Edgewood, Kentucky, United States

Esophageal Institute of Atlanta, PC.; 🇺🇸 Atlanta, Georgia, United States

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States

Cuyuna Regional Medical Center; 🇺🇸 Crosby, Minnesota, United States

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Adirondack Surgical Group, LLC; 🇺🇸 Saranac Lake, New York, United States

Knox Community Hospital; 🇺🇸 Mount Vernon, Ohio, United States

The Oregon Clinic; 🇺🇸 Portland, Oregon, United States

Scott and White Memorial Hospital; 🇺🇸 Round Rock, Texas, United States

Gundersen Lutheran; 🇺🇸 La Crosse, Wisconsin, United States

University Hospitals Cleveland Medical Center - Geauga; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States