A Post-Approval Study of the LINX® Reflux Management System
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- Device: LINX device
- Registration Number
- NCT01940185
- Lead Sponsor
- Torax Medical Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LINX device LINX device Patients implanted with the LINX® Reflux Management System.
- Primary Outcome Measures
Name Time Method Serious, device-related adverse events 60 months 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.
Reduction of total GERD-HRQL score 6 months, 12 months, and annually to 60 months Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
- Secondary Outcome Measures
Name Time Method pH Measurements The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months) Reduction from baseline in Total % time esophageal pH\<4
Related Adverse Events 120 months Incidence rate of of device- and/or procedure-related adverse events
Reduction of Symptoms The secondary measurements will be evaluated at yearly interval to 120 months 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.
Related Research Topics
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Trial Locations
- Locations (19)
Keck Medical Center of Univeristy of Southern California
🇺🇸Los Angeles, California, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Albany Surgical
🇺🇸Albany, Georgia, United States
Cuyuna Regional Medical Center
🇺🇸Crosby, Minnesota, United States
Candler Hospital
🇺🇸Savannah, Georgia, United States
University of California San Diego
🇺🇸San Diego, California, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
VIP Surg PLLC
🇺🇸Las Vegas, Nevada, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University Hospitals Cleveland Medical Center - Geauga
🇺🇸Cleveland, Ohio, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Allegheny Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Medical Center/SurgOne
🇺🇸Englewood, Colorado, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Beth Israel
🇺🇸Boston, Massachusetts, United States
Froedtert and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Bingham Memorial Hospital
🇺🇸Blackfoot, Idaho, United States
Virginia Hospital Center
🇺🇸Arlington, Virginia, United States
Esophageal Institute of Atlanta, PC.
🇺🇸Atlanta, Georgia, United States