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Which surgery keeps hiatal hernias away longer? study aims to find out

NCT ID NCT04695171

Knowledge-focused Sponsor: Foregut Research Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry tracked 336 adults who had surgery for a large hiatal hernia (over 3 cm) at least two years earlier. Some received a LINX magnetic implant to strengthen the valve between the stomach and esophagus, while others had a fundoplication (wrapping the stomach around the esophagus). The goal was to see which method better prevents the hernia from coming back. However, the study was terminated early, so the full picture is unclear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LINX Reflux Management System (magnetic bead implant) or fundoplication surgery
What this could lead to
If successful, this could help doctors choose the best surgical option to prevent hiatal hernias from coming back after repair.
What could go wrong
The study was terminated early, so results may be incomplete. It only looks back at past surgeries, not a controlled experiment, so findings are less reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

336 people

The number who actually took part.

Started

Jan 2021

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease hiatus hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastro esophageal reflux Hiatal hernia Hiatal hernia large Hiatal hernia, paraesophageal Reflux acid Reflux, gastroesophageal

Contacts and locations

Locations

  • East Carolina University

    Greenville, North Carolina, 27858, United States

  • Esophageal Institute

    Pittsburgh, Pennsylvania, 15224, United States

  • Institute of Esophageal and Reflux Surgery

    Lone Tree, Colorado, 80124, United States

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • South Florida Reflux Center

    Coral Springs, Florida, 33065, United States

  • University of Texas

    Austin, Texas, 78712, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.