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NCT04695171 · ClinicalTrials.gov registry record
LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
A clinical trial, sponsored by Foregut Research Foundation.
- Terminated
- Registry status
- 336
- Enrollment target
NCT04695171: Clinical Trial study, sponsored by Foregut Research Foundation.
NCT04695171 is a clinical trial that was terminated before completion, run by Foregut Research Foundation. The registered enrollment target is 336 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04695171 was terminated before completion, sponsored by Foregut Research Foundation.
- TERMINATED
- Registry status
- 336 participants
- Enrollment target
Study Summary
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.
Primary Outcome
The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo primary hiatal hernia repair of a large (\>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who undergo hiatal hernia repair with fundoplication.
Interventions
- DEVICE LINX Reflux Management System
- PROCEDURE Fundoplication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2026-01-14 |
Why NCT04695171 stopped before completion
NCT04695171 is an observational study that tracks outcomes without assigning an intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which LINX Reflux Management System is the first listed.
NCT04695171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04695171 about?
NCT04695171 is a clinical study titled "LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm". The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.
What is the current status of trial NCT04695171?
This trial is currently terminated. The enrollment target is 336 participants. The study started on 2021-01-14. Estimated completion is 2026-01-14.
What interventions are being tested in trial NCT04695171?
The interventions under investigation include: LINX Reflux Management System (DEVICE), Fundoplication (PROCEDURE).
Who is sponsoring clinical trial NCT04695171?
This trial is sponsored by Foregut Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
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