5348W-12 LINX® GERD Management Post-Approval Study

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

Type of Study
Thoracic
Location
Swedish Thoracic Surgery / First Hill
Short Description

Purpose:  This is 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. 

The study population for this trial is patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

Status
Open to Enrollment
Principal Investigator
Brian Louie, M.D.
Eligibility Notes

Inclusion Criteria:

  • Aged 21 Years or over
  • 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.

Exclusion Criteria:

  • 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.
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Contact Name
Tina Brennan
Phone
(206) 386-2450
Email
christina.brennan@swedish.org