A Post-Approval Study of the LINX® Reflux Management System
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/31/2019 |
| Start Date: | June 2012 |
| End Date: | October 2025 |
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.
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.
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.
We found this trial at
19
sites
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
Click here to add this to my saved trials
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
Click here to add this to my saved trials