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Can a less invasive reflux surgery match the standard one?

NCT ID NCT04795934

Disease control Sponsor: Mayo Clinic 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial compares two surgical procedures for people with gastroesophageal reflux disease (GERD) and a hiatal hernia. One procedure, called transoral incisionless fundoplication (TIF), is done through the mouth without cuts. The other, laparoscopic Nissen fundoplication (LNF), is a standard minimally invasive surgery. Researchers will randomly assign 142 participants to one of the two procedures and measure quality of life six months later to see if TIF works as well as LNF.

What this could mean

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

Active substance
Two surgical procedures: transoral incisionless fundoplication (TIF) and laparoscopic Nissen fundoplication (LNF), both combined with hiatal hernia repair
What this could lead to
If TIF works as well as LNF, patients could choose a less invasive option with similar relief from acid reflux and heartburn.
What could go wrong
This is a randomized trial, but results may not apply to everyone. TIF might not match LNF's effectiveness, and both procedures carry surgical risks like difficulty swallowing or bloating.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Jan 2030

An estimate. End dates often move.

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.

Ages

22 to 80 years

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. 22-80 years of age 2. Subjects have GERD with hiatal hernia \< 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV 3. Pathologic reflux while off PPI based on Lyon criteria by either of the following: 3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis. 3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B. 4. Commitment to long-term study 5. Ability to give consent individually or by a legally authorized representative Exclusion Criteria: 1. Hiatal hernia \> 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) 2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator 3. Pregnancy (in females) at time of procedure 4. Previous anti-reflux procedure 5. Subjects requiring mesh treatment at time of procedure 6. At the discretion of the site PI for subject safety 7. BMI \> 35 at time of surgery. 8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty. 9. Severe gastroparesis

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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.

GERD Hiatal hernia

Contacts and locations

Locations

  • Fox Valley Surgical

    Appleton, Wisconsin, 54911, United States

  • Institute of Esophageal and Reflux Surgery

    Englewood, Colorado, 880113, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • The University of Texas at Austin

    Austin, Texas, 78712, United States

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

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