GERD Gastroesophageal Reflux DiseasePhase 4CALIBERNCT02505945
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
A Phase 4 study testing Omeprazole and LINX Reflux Management System in people with GERD Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 21 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- GERD Gastroesophageal Reflux Disease
- What is being tested?
- Omeprazole and LINX Reflux Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2015to Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Albany Surgical PC
Albany, Georgia
Anne Arundel Medical Center
Annapolis, Maryland
Esophageal Institute of Atlanta, PC.
Atlanta, Georgia, 30309
University Hospitals Cleveland Medical Center - Geauga
Cleveland, Ohio, 44106
Cuyuna Regional Medical Center
Crosby, Minnesota, 56441
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
SurgOne Foregut Institute
Englewood, Colorado, 80110
Bapist Health
Heber Springs, Arkansas
Gundersen Lutheran
La Crosse, Wisconsin
University of Southern California
Los Angeles, California
Medical College of Wisconsin
Milwaukee, Wisconsin
University of South Alabama
Mobile, Alabama, 36617
Knox Community Hospital
Mount Vernon, Ohio
Jersey Shore University Medical Center
Neptune City, New Jersey
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
The Oregon Clinic
Portland, Oregon
Scott and White Memorial Hospital
Round Rock, Texas, 78665
UCSD
San Diego, California
Adirondack Surgical Group, LLC
Saranac Lake, New York
Swedish Cancer Institute
Seattle, Washington
About this study
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).
Read the 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).
- Conditions
- GERD Gastroesophageal Reflux Disease
- Being tested
- Omeprazole, LINX Reflux Management System
- Keywords
- Esophageal Reflux, Gastric Acid Reflux Disease, Heartburn
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec
LINX Reflux Management SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Double-dose PPI [Omeprazole 20 mg BID (twice a day)] Receives: Drug: Omeprazole |
| Treatment Arm | Active comparator | LINX Reflux Management System Receives: Device: LINX Reflux Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GERD Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torax Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505945
- Sponsor's protocol ID
- 4959
- Acronym
- CALIBER
- Status last verified
- Dec 2018
- First submitted
- 21 Jul 2015
- Last updated
- 7 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32467089Bell 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.
PubMed 31518717Bell 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.
PubMed 30031018
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
- ClinicalTrials.gov ID
- NCT02505945
- Acronym / sponsor ID
- CALIBER / 4959
- Conditions
- GERD Gastroesophageal Reflux Disease
- Keywords
- Esophageal Reflux, Gastric Acid Reflux Disease, Heartburn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: OmeprazoleDouble-dose PPI [Omeprazole 20 mg BID (twice a day)] |
| Treatment Arm | Active comparator | Device: LINX Reflux Management SystemLINX Reflux Management System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Prilosec | Drug | Control Arm |
| LINX Reflux Management System | Device | Treatment Arm |
Primary outcome
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.
1 secondary outcome
Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32467089Rogers 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.
- Derived from this study: PubMed 31518717Bell 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.
- Derived from this study: PubMed 30031018Bell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole and LINX Reflux Management System in people with GERD Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elimination of Moderate-severe Regurgitation at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505945, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.