The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
CALIBER
1 other identifier
interventional
152
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2015
Typical duration for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 21, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
December 12, 2018
CompletedJanuary 7, 2019
December 1, 2018
2.3 years
July 21, 2015
November 15, 2018
December 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores
6 months
Study Arms (2)
Control Arm
ACTIVE COMPARATORDouble-dose PPI \[Omeprazole 20 mg BID (twice a day)\]
Treatment Arm
ACTIVE COMPARATORLINX Reflux Management System
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
University of South Alabama
Mobile, Alabama, 36617, United States
Bapist Health
Heber Springs, Arkansas, United States
University of Southern California
Los Angeles, California, United States
UCSD
San Diego, California, United States
SurgOne Foregut Institute
Englewood, Colorado, 80110, United States
Albany Surgical PC
Albany, Georgia, United States
Esophageal Institute of Atlanta, PC.
Atlanta, Georgia, 30309, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Cuyuna Regional Medical Center
Crosby, Minnesota, 56441, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Adirondack Surgical Group, LLC
Saranac Lake, New York, United States
University Hospitals Cleveland Medical Center - Geauga
Cleveland, Ohio, 44106, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Scott and White Memorial Hospital
Round Rock, Texas, 78665, United States
Swedish Cancer Institute
Seattle, Washington, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Related Publications (3)
Rogers BD, Valdovinos LR, Crowell MD, Bell R, Vela MF, Gyawali CP. Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation. Gut. 2021 Mar;70(3):450-455. doi: 10.1136/gutjnl-2020-321395. Epub 2020 May 28.
PMID: 32467089DERIVEDBell R, Lipham J, Louie BE, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP 3rd, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1736-1743.e2. doi: 10.1016/j.cgh.2019.08.056. Epub 2019 Sep 10.
PMID: 31518717DERIVEDBell R, Lipham J, Louie B, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP 3rd, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc. 2019 Jan;89(1):14-22.e1. doi: 10.1016/j.gie.2018.07.007. Epub 2018 Jul 18.
PMID: 30031018DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Ahlstrom
- Organization
- Torax Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2015
First Posted
July 22, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2017
Study Completion
August 1, 2018
Last Updated
January 7, 2019
Results First Posted
December 12, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share