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New surgical approach aims to spare nerves and improve life for GERD patients

NCT ID NCT07252115

Disease control Sponsor: Beijing Friendship Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new nerve-sparing surgery (TLSA) to the standard surgery for people with hiatal hernia and GERD. The goal is to see if the new approach improves quality of life by avoiding damage to a key nerve. About 143 adults will take part in this randomized trial.

What this could mean

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

Active substance
Total left-side surgical approach (TLSA) - a nerve-sparing laparoscopic procedure
What this could lead to
If successful, this surgical technique could reduce side effects like swallowing problems and improve quality of life for people with hiatal hernia and GERD.
What could go wrong
This is a relatively small, early-stage trial. The new approach may not prove better than the standard surgery, and all surgeries carry risks like infection or nerve injury.

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 143 people

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

Started

Apr 2024

Expected to finish

Dec 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 to 85 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: * Patients aged 18 to 85 years. * Confirmed diagnosis of hiatal hernia (type I to IV). * Diagnosis of refractory GERD, defined as persistent symptoms despite receiving 40 mg daily omeprazole for 8-12 weeks. * GERD confirmed by either: * Increased esophageal acid exposure time (AET) on 24-hour pH monitoring, and/or * Endoscopic evidence of esophagitis. * Hiatal hernia diagnosis verified by both abdominal CT and gastroscopy. Exclusion Criteria: * Presence of GERD without a hiatal hernia. * Esophageal motility disorder. * History of esophageal or other upper abdominal surgery.

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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 (gastroesophageal reflux disease) Hernia, hiatal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Friendship Hospital

    ACTIVE_NOT_RECRUITING

    Beijing, 100050, China

  • Beijing Friendship Hospital

    RECRUITING

    Beijing, 100050, China

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