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NCT01940185 · ClinicalTrials.gov registry record
A Post-Approval Study of the LINX® Reflux Management System
A clinical trial, sponsored by Torax Medical Incorporated.
- Completed
- Registry status
- 200
- Enrollment target
NCT01940185: Completed study, sponsored by Torax Medical Incorporated.
NCT01940185 is a clinical trial that has completed, run by Torax Medical Incorporated. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01940185 has completed, sponsored by Torax Medical Incorporated.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
Interventions
- DEVICE LINX device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-06-30 |
| Est. Completion | 2023-06-30 |
What the finished NCT01940185 record still lists
NCT01940185 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which LINX device is the first listed.
NCT01940185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01940185 about?
NCT01940185 is a clinical study titled "A Post-Approval Study of the LINX® Reflux Management System". 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.
What is the current status of trial NCT01940185?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2012-06-30. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT01940185?
The interventions under investigation include: LINX device (DEVICE).
Who is sponsoring clinical trial NCT01940185?
This trial is sponsored by Torax Medical Incorporated, which has 6 total clinical trials registered on ClinicalTrials.gov.
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