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

Completed

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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.

Key facts

Study ID

NCT01940185

Run by

Torax Medical Incorporated

People needed

200

Starts

2012-06-30

Expected to finish

2023-06-30

Last updated by the study team

2024-01-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Keck Medical Center of Univeristy of Southern California — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• Swedish Medical Center/SurgOne — Englewood, Colorado, United States
• Albany Surgical — Albany, Georgia, United States
• Esophageal Institute of Atlanta, PC. — Atlanta, Georgia, United States
• Candler Hospital — Savannah, Georgia, United States
• Bingham Memorial Hospital — Blackfoot, Idaho, United States
• Beth Israel — Boston, Massachusetts, United States
• Cuyuna Regional Medical Center — Crosby, Minnesota, United States
• VIP Surg PLLC — Las Vegas, Nevada, United States
• University Hospitals Cleveland Medical Center - Geauga — Cleveland, Ohio, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Knox Community Hospital — Mount Vernon, Ohio, United States
• The Oregon Clinic — Portland, Oregon, United States
• Allegheny Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• Virginia Hospital Center — Arlington, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States
• Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
• Froedtert and Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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