Gastroesophageal Reflux Disease (GERD)
Conditions
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.
Interventions
DEVICELINX device
Sponsors
Torax Medical Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Related Adverse Events | 120 months | Incidence rate of of device- and/or procedure-related adverse events |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed