Phase 4
N=152
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
GERD Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT02505945 ↗Enrolled (actual)
152
Serious AEs
0.7%
Results posted
Dec 2018
Primary outcome: Primary: Elimination of Moderate-severe Regurgitation at 6 Months — 10; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omeprazole (Drug); LINX Reflux Management System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Torax Medical Incorporated
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Elimination of Moderate-severe Regurgitation at 6 Months |
10; 42 | — |
| SECONDARY Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores |
7; 38 | — |
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).
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02505945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.