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

NCT04695171 | Terminated FDA Device

• 1 other identifier: TRX-2019-02
• Study Type: observational
• Target: 336
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

GERD; LINX; Fundoplication; MSA; Magnetic Sphincter Augmentation; MSAD; Magnetic Sphincter Augmentation Device

Outcome Measures

Primary Outcomes (1)

• Incidence of Hiatal Hernia Recurrence

  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.

  Up to 5 years post index procedure

Secondary Outcomes (2)

• Incidence of Repeat Surgical Intervention

  5 years

• Understanding Patient Reported Symptom Control

  5 years

Study Arms (2)

Prior Primary Large Hiatal Hernia with LINX Placement MSA

Patients who were previously implanted with the LINX device during repair of a hiatal hernia \>3 cm \>2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at 3 and 5 years to determine recurrence of hiatal hernia.

Device: LINX Reflux Management System

Prior Primary Large Hiatal Hernia with Fundoplication

Patients who previously underwent lower esophageal sphincter reconstruction by fundoplication during repair of a hiatal hernia \>3 cm \>2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at about 3 and 5 years to determine recurrence of hiatal hernia.

Procedure: Fundoplication

Interventions

LINX Reflux Management System DEVICE

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.

Also known as: Magnetic Augmentation System, Magnetic Sphincter Augmentation Device, MSAD, Magnetic Sphincter Augmentation, MSA

Prior Primary Large Hiatal Hernia with LINX Placement MSA

Fundoplication PROCEDURE

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.

Also known as: Nissen fundoplication, Partial fundoplication, Toupet fundoplication, Watson fundoplication, Dor fundoplication

Prior Primary Large Hiatal Hernia with Fundoplication

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical evaluation will be conducted at four U.S. investigational centers with up to one hundred and fifty(150) subjects per center (goal of 450 total). Corhort 1 will consist of 300 subjects who were implanted with the LINX® Reflux Management System in the manner described above more than 2 years prior to enrollment to this study. Cohort 2 will consist of 150 subjects who underwent a fundoplication more that 2 years prior to enrollment into this study with similar hiatal hernia size and similar effective esophageal motility.

You may qualify if:

• Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
• Underwent primary index procedure of laparoscopic repair of a hiatal hernia larger than 3 cm with placement of a LINX® device or construction of a fundoplication for reflux control more than 2 years prior to his/her enrollment or has completed 1 or 2 of the barium swallows and GERD-HRQLs within study time points with or without hiatal hernia recurrence.
• Subject is willing and able to cooperate with follow-up examinations.
• Subject has been informed of the study procedures and treatment and has signed an informed consent.

You may not qualify if:

• The surgical procedure was completed as an emergency procedure
• Currently being treated with another investigational drug or investigational device
• Suspected or confirmed esophageal or gastric cancer
• Subject has Barrett's esophagus \>3cm
• Cannot understand trial requirements or is unable to comply with follow-up schedule
• Pregnant or plans to become pregnant during the course of the study
• Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
• Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.

Sponsors & Collaborators

• Foregut Research Foundation: lead

Study Sites (6)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Institute of Esophageal and Reflux Surgery

Lone Tree, Colorado, 80124, United States

Location

South Florida Reflux Center

Coral Springs, Florida, 33065, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Esophageal Institute

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Reginald Bell, M.D.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: January 14, 2021
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (6)