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Can surgery offer lasting relief for chronic heartburn? a large registry investigates

NCT ID NCT02923362

Disease control Sponsor: The Heartburn 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This registry follows thousands of adults who undergo laparoscopic surgery for gastroesophageal reflux disease (GERD) or hiatal hernia. It compares two common procedures: fundoplication, which wraps part of the stomach around the esophagus to reinforce the valve, and the LINX device, a magnetic ring that helps keep acid from backing up. The goal is to see how patients' quality of life changes after surgery and whether one approach offers better long-term outcomes.

What this could mean

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

Active substance
Laparoscopic fundoplication (a surgical procedure that wraps the top of the stomach around the lower esophagus to strengthen the valve) and the LINX device (a magnetic ring implanted around the esophagus to help keep stomach acid from flowing back up).
What this could lead to
If successful, this registry could clarify which surgical approach offers better long-term quality of life for people with chronic acid reflux or hiatal hernia, helping guide treatment decisions.
What could go wrong
As a registry, it does not randomly assign treatments, so comparisons may be biased. Surgery carries risks like difficulty swallowing, bloating, or recurrence of symptoms, and results may not apply to all patients.

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

1,941 people

The number who actually took part.

Start date

May 2016

Finished

May 2023

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

Male and female patient over the age of 21 with no maximum age who meet the eligibility for anti reflux and or hiatal hernia repair surgery

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: * Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law. * Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery. * Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)). * 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 for the study. Exclusion Criteria: * Suspected or confirmed esophageal or gastric cancer. * Cannot understand trial requirements or is unable to comply with follow-up schedule * Pregnant or nursing, 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.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Heartburn hiatus hernia Laryngopharyngeal Reflux

As listed by the trial registrant

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

Gastroesophageal reflux disease Hiatal hernia

Contacts and locations

Locations

  • Advanced Surgeons, PC

    Birmingham, Alabama, 35243, United States

  • Affinity Medical Group

    Chilton, Wisconsin, 53014, United States

  • Bass Medical Group

    Walnut Creek, California, 94598, United States

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75204, United States

  • Baylor University Medical Center at Dallas

    Dallas, Texas, 75246, United States

  • Coastal Carolina Bariatric and Surgical Center

    Summerville, South Carolina, 29485, United States

  • Froedtert & The Medical College of Wisconsin Hospitals and Health Partners

    Milwaukee, Wisconsin, 53226, United States

  • HealthOne Cardiothoracic Surgery Associates

    Aurora, Colorado, 80012, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Institute of Esophageal and Reflux Surgery

    Englewood, Colorado, 80113, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • North Texas Surgical Oncology Associates

    Plano, Texas, 75075, United States

  • South Florida Surgical Specialists, LLC

    Coral Springs, Florida, 33065, United States

  • Suncoast Surgical Associates

    Brandon, Florida, 33511, United States

  • Swedish Health Services

    Seattle, Washington, 98103, United States

  • Tampa Bay Reflux Center

    Riverview, Florida, 33578, United States

  • The Arkansas Heartburn Treatment Center

    Heber Springs, Arkansas, 72543, United States

  • The Tampa Bay Reflux Center

    Tampa, Florida, 33609, United States

  • University of Southern Alabama

    Mobile, Alabama, 36617, United States

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