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Surgery insight: how hernia repair affects the stomach valve

NCT ID NCT04450628

Knowledge-focused Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how hiatal hernia repair surgery changes the flexibility of the junction between the esophagus and stomach. Researchers will use a special balloon device during surgery to measure this flexibility in 25 adults. They hope to find links between these measurements and patients' later symptoms like heartburn or trouble swallowing.

What this could mean

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

Active substance
EndoFLIP device
What this could lead to
If successful, this could help surgeons tailor hiatal hernia repairs to improve patient outcomes like reflux and swallowing.
What could go wrong
This is a small, early-stage observational study with only 25 participants, so results may not apply broadly. The device is used during surgery and carries standard procedural risks.

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 25 people

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

Started

Sep 2020

Expected to finish

Sep 2026

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

18 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: * Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication * Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry * Adult patients ≥18 years * Elective repairs Exclusion Criteria: * Redo hiatal hernia repairs * Emergent repairs * Patients with contraindication to surgery or endoscopy * Patients with esophageal varices * Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required * Connective tissue diseases such as scleroderma or lupus * Diameter measurements less than 5 mm as the EF-325N catheter is not suitable

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Conditions

The condition(s) this trial relates to.

hiatus hernia

As listed by the trial registrant

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

Esophagogastric junction distensibility Hiatal hernia

Contacts and locations

Locations

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

More trials for these conditions

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