A Post-Approval Study of the LINX® Reflux Management System
NCT01940185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2024-01-05
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.
Conditions
- Gastroesophageal Reflux Disease (GERD)
Interventions
- DEVICE
-
LINX device
Sponsors & Collaborators
-
Torax Medical Incorporated
lead INDUSTRY
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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