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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: LINX device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LINX device<br>Patients implanted with the LINX® Reflux Management System. | Device: LINX device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of total GERD-HRQL score | Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline. | 6 months, 12 months, and annually to 60 months | 
| Serious, device-related adverse events | Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Related Adverse Events | Incidence rate of of device- and/or procedure-related adverse events | 120 months | 
| pH Measurements | Reduction from baseline in Total % time esophageal pH<4 | The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months) | 
| Reduction of Symptoms | Reduction from baseline on Foregut Symptom Questionnaire (frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile). No formal statistical hypothesis tests will be conducted. Any statistical analyses will be primarily descriptive. | The secondary measurements will be evaluated at yearly interval to 120 months |