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NCT02505945 · ClinicalTrials.gov registry record · Phase 4
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
A Phase 4 study of GERD Gastroesophageal Reflux Disease, sponsored by Torax Medical Incorporated.
- Completed
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT02505945: Completed Phase 4 study of GERD Gastroesophageal Reflux Disease, sponsored by Torax Medical Incorporated.
NCT02505945 is a Phase 4 study of GERD Gastroesophageal Reflux Disease that has completed, run by Torax Medical Incorporated. The registered enrollment target is 152 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02505945, a Phase 4 study of GERD Gastroesophageal Reflux Disease, has completed, sponsored by Torax Medical Incorporated.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Omeprazole
- DEVICE LINX Reflux Management System
Study Locations (20)
California
- University of Southern California - Los Angeles
- UCSD - San Diego
Georgia
- Albany Surgical PC - Albany
- Esophageal Institute of Atlanta, PC. - Atlanta
Ohio
- University Hospitals Cleveland Medical Center - Geauga - Cleveland
- Knox Community Hospital - Mount Vernon
Pennsylvania
- Albert Einstein Healthcare Network - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Alabama
- University of South Alabama - Mobile
Arkansas
- Bapist Health - Heber Springs
Colorado
- SurgOne Foregut Institute - Englewood
Kentucky
- St. Elizabeth Healthcare - Edgewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-08 |
| Phase | Phase 4 |
What the finished NCT02505945 record still lists
NCT02505945 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 1 condition, with GERD Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 2 interventions - of which Omeprazole is the first listed.
NCT02505945 names 20 study sites across 16 states, led by California, Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT02505945 about?
NCT02505945 is a clinical study titled "The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease". 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).
What is the current status of trial NCT02505945?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2015-06. Estimated completion is 2018-08.
What conditions does trial NCT02505945 study?
This clinical trial studies the following conditions: GERD Gastroesophageal Reflux Disease.
What interventions are being tested in trial NCT02505945?
The interventions under investigation include: Omeprazole (DRUG), LINX Reflux Management System (DEVICE).
Who is sponsoring clinical trial NCT02505945?
This trial is sponsored by Torax Medical Incorporated, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02505945 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02505945's enrollment target sits among peer trials
152 530th of 2000 higher than 1,469 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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