Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 16 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02505945
The ClinicalTrials.gov registry entry for NCT02505945 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Torax Medical Incorporated, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.