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

December 12, 2018 updated by: Torax Medical Incorporated
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama
    • Arkansas
      • Heber Springs, Arkansas, United States
        • Bapist Health
    • California
      • Los Angeles, California, United States
        • University of Southern California
      • San Diego, California, United States
        • UCSD
    • Colorado
      • Englewood, Colorado, United States, 80110
        • SurgOne Foregut Institute
    • Georgia
      • Albany, Georgia, United States
        • Albany Surgical PC
      • Atlanta, Georgia, United States, 30309
        • Esophageal Institute of Atlanta, PC.
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Healthcare
    • Maryland
      • Annapolis, Maryland, United States
        • Anne Arundel Medical Center
    • Minnesota
      • Crosby, Minnesota, United States, 56441
        • Cuyuna Regional Medical Center
    • New Jersey
      • Neptune, New Jersey, United States
        • Jersey Shore University Medical Center
    • New York
      • Saranac Lake, New York, United States
        • Adirondack Surgical Group, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center - Geauga
      • Mount Vernon, Ohio, United States
        • Knox Community Hospital
    • Oregon
      • Portland, Oregon, United States
        • The Oregon Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Healthcare Network
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Round Rock, Texas, United States, 78665
        • Scott and White Memorial Hospital
    • Washington
      • Seattle, Washington, United States
        • Swedish Cancer Institute
    • Wisconsin
      • La Crosse, Wisconsin, United States
        • Gundersen Lutheran
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
Drug: Omeprazole
Other Names:
  • Prilosec
Active Comparator: Treatment Arm
LINX Reflux Management System
Device: LINX Reflux Management System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elimination of Moderate-severe Regurgitation at 6 Months
Time Frame: 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
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torax Medical Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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