Summary

for people ages 21 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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).

Details

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).

Keywords

GERD Gastroesophageal Reflux Disease Esophageal Reflux Gastric Acid Reflux Disease Heartburn Gastroesophageal Reflux Omeprazole Proton Pump Inhibitors LINX Reflux Management System

Eligibility

For people ages 21 years and up

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.

Locations

  • UCSD
    San Diego California United States
  • University of Southern California
    Los Angeles California United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Torax Medical Incorporated
ID
NCT02505945
Phase
Phase 4
Study Type
Interventional
Last Updated
April 23, 2018