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LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

NCT04695171 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 336

Last updated 2026-02-09

No results posted yet for this 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.

Conditions

  • Hiatal Hernia Large
  • Gastro Esophageal Reflux
  • Hiatal Hernia
  • Hiatal Hernia, Paraesophageal
  • Reflux, Gastroesophageal
  • Reflux Acid

Interventions

DEVICE

LINX Reflux Management System

The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.

PROCEDURE

Fundoplication

A surgical procedure where the fundus of the stomach is wrapped around and sutured to the distal esophagus to restore the function of the lower esophageal sphincter in limiting stomach contents from refluxing into the esophagus.

Sponsors & Collaborators

  • Foregut Research Foundation

    lead OTHER

Principal Investigators

  • Reginald Bell, M.D. · Principal Investigator

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2026-01-14
Completion
2026-01-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695171 on ClinicalTrials.gov