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

September 11, 2023 updated by: Foregut Research Foundation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medical Center of USC
        • Contact:
        • Principal Investigator:
          • Luke Putnam, M.D.
        • Sub-Investigator:
          • John Lipham, M.D.
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Institute of Esophageal and Reflux Surgery
        • Principal Investigator:
          • Reginald Bell, M.D.
        • Contact:
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • South Florida Reflux Center
        • Contact:
        • Principal Investigator:
          • Mark Schachner, M.D.
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Recruiting
        • East Carolina University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos J Anciano, M.D.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Active, not recruiting
        • Esophageal Institute
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • University of Texas
        • Principal Investigator:
          • Francis Buckley, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
  2. 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.
  3. Subject is willing and able to cooperate with follow-up examinations.
  4. Subject has been informed of the study procedures and treatment and has signed an informed consent.

Exclusion Criteria:

  1. The surgical procedure was completed as an emergency procedure
  2. Currently being treated with another investigational drug or investigational device
  3. Suspected or confirmed esophageal or gastric cancer
  4. Subject has Barrett's esophagus >3cm
  5. Cannot understand trial requirements or is unable to comply with follow-up schedule
  6. Pregnant or plans to become pregnant during the course of the study
  7. 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)
  8. Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Magnetic Augmentation System
  • Magnetic Sphincter Augmentation Device, MSAD
  • Magnetic Sphincter Augmentation, MSA
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
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.
Other Names:
  • Nissen fundoplication
  • Partial fundoplication
  • Toupet fundoplication
  • Watson fundoplication
  • Dor fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hiatal Hernia Recurrence
Time Frame: Up to 5 years post index procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Repeat Surgical Intervention
Time Frame: 5 years
A secondary objectives are to determine the incidence of repeat surgical intervention with recurrent hernias in patients who received a LINX verses fundoplication.
5 years
Understanding Patient Reported Symptom Control
Time Frame: 5 years
A secondary objective is to understand patient-reported symptom control including PPI use, occurrence rate of gas and bloating, and ability to belch and vomit as measured by comparison of pre- and post-operative satisfaction and ROARS Questionnaire (GERD-Health related quality of life [HRQL]) surveys during multiple follow-up time points.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foregut Research Foundation

Investigators

  • Principal Investigator: Reginald Bell, M.D., Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRX-2019-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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