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

Torax Medical

Status: Completed

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Device: LINX device

Study type: Observational

Funder types: Industry

Identifiers

NCT01940185

3545

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Trial design

200 participants in 1 patient group

LINX device

Description:

Patients implanted with the LINX® Reflux Management System.

Treatment:

Device: LINX device