Overview

This trial is active, not recruiting.

Condition gastroesophageal reflux disease (gerd)
Treatment linx device
Sponsor Torax Medical Incorporated
Start date June 2012
End date September 2019
Trial size 200 participants
Trial identifier NCT01940185, 3545

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
linx device

Primary Outcomes

Measure
Successful reduction of total GERD-HRQL score
time frame: 6 months, 12 months, and annually to 60 months
Serious, device-related adverse events
time frame: 60 months

Secondary Outcomes

Measure
Incidence rate of device-related adverse events, reduction in use of daily acid suppression therapy, frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile
time frame: 6 months, 12 months, and annually to 60 months

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title A Post-Approval Study of the LINX® Reflux Management System
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Torax Medical Incorporated.