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Cohort Registry on 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.
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo 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 underwent hiatal hernia repair with fundoplication.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Keck Medical Center of USC
Los Angeles, California, United States
Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, United States
South Florida Reflux Center
Coral Springs, Florida, United States
East Carolina University
Greenville, North Carolina, United States
Esophageal Institute
Pittsburgh, Pennsylvania, United States
University of Texas
Austin, Texas, United States
Start Date
January 14, 2021
Primary Completion Date
January 14, 2026
Completion Date
January 14, 2026
Last Updated
February 9, 2026
336
ACTUAL participants
LINX Reflux Management System
DEVICE
Fundoplication
PROCEDURE
Lead Sponsor
Foregut Research Foundation
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07131397