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
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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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...
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Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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