Overview

The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Torax Medical Incorporated
Treatments:
Omeprazole
Proton Pump Inhibitors
Criteria
Key Inclusion Criteria:

1. Patient seeks consultation for lack of satisfactory symptom response to once daily
PPIs.

2. Ageā‰„ 21 years old.

3. 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.

4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and
laparoscopic surgery).

5. Patient has provided written informed consent for participation in the randomized
study.

Key Exclusion Criteria:

1. Currently taking double-dose PPIs (twice daily dosing).

2. Hiatal hernia >3cm as determined by endoscopy.

3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.

4. Esophagitis Grade C or D (Los Angeles classification).

5. Body mass index >35.

6. Diagnosed with an esophageal motility disorder LES.

7. Esophageal stricture or gross esophageal anatomic abnormalities

8. History of/or known Barrett's esophagus.

9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous
materials.