Back to resultsThe CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease (CALIBER)
Primary Purpose
GERD Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omeprazole
LINX Reflux Management System
Sponsored by
About this trial
This is an interventional treatment trial for GERD Gastroesophageal Reflux Disease focused on measuring Esophageal Reflux, Gastric Acid Reflux Disease, Heartburn
Eligibility Criteria
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.
Sites / Locations
- University of South Alabama
- Bapist Health
- University of Southern California
- UCSD
- SurgOne Foregut Institute
- Albany Surgical PC
- Esophageal Institute of Atlanta, PC.
- St. Elizabeth Healthcare
- Anne Arundel Medical Center
- Cuyuna Regional Medical Center
- Jersey Shore University Medical Center
- Adirondack Surgical Group, LLC
- University Hospitals Cleveland Medical Center - Geauga
- Knox Community Hospital
- The Oregon Clinic
- Albert Einstein Healthcare Network
- University of Pittsburgh Medical Center
- Scott and White Memorial Hospital
- Swedish Cancer Institute
- Gundersen Lutheran
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Arm
Treatment Arm
Arm Description
Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
LINX Reflux Management System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02505945
First Posted
July 21, 2015
Last Updated
December 12, 2018
Sponsor
Torax Medical Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT02505945
Brief Title
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Acronym
CALIBER
Official Title
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torax Medical Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD Gastroesophageal Reflux Disease
Keywords
Esophageal Reflux, Gastric Acid Reflux Disease, Heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
LINX Reflux Management System
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Prilosec
Intervention Type
Device
Intervention Name(s)
LINX Reflux Management System
Primary Outcome Measure Information:
Title
Elimination of Moderate-severe Regurgitation at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Bapist Health
City
Heber Springs
State/Province
Arkansas
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
Country
United States
Facility Name
SurgOne Foregut Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Albany Surgical PC
City
Albany
State/Province
Georgia
Country
United States
Facility Name
Esophageal Institute of Atlanta, PC.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
St. Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
Cuyuna Regional Medical Center
City
Crosby
State/Province
Minnesota
ZIP/Postal Code
56441
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
Country
United States
Facility Name
Adirondack Surgical Group, LLC
City
Saranac Lake
State/Province
New York
Country
United States
Facility Name
University Hospitals Cleveland Medical Center - Geauga
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Gundersen Lutheran
City
La Crosse
State/Province
Wisconsin
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32467089
Citation
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.
Results Reference
derived
PubMed Identifier
31518717
Citation
Bell 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.
Results Reference
derived
PubMed Identifier
30031018
Citation
Bell 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.
Results Reference
derived
Learn more about this trial
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
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