This study is in progress, not accepting new patients

A Post-Approval Study of the LINX® Reflux Management System

a study on GERD

Summary

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

Description

Summary

A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.

Keywords

Gastroesophageal Reflux Disease (GERD), Gastroesophageal Reflux, LINX device

Eligibility

You can join if…

Open to people ages 21 years and up

  • Patient is a candidate for treatment with the LINX Reflux Management System
  • Patient has provided written informed consent for participation in the post-approval study.
  • Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
  • Patient has been diagnosed with GERD as defined by abnormal pH testing.
  • Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

You CAN'T join if...

  • Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
  • Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.

Locations

  • University of California San Diego
    San Diego California 92103 United States
  • Keck Medical Center of Univeristy of Southern California
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Torax Medical Incorporated
ID
NCT01940185
Study Type
Observational
Participants
About 200 people participating
Last Updated