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New combo surgery for obesity and reflux tested – but study stopped early

NCT ID NCT04626232

Disease control Sponsor: University Hospital, Montpellier 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to compare a standard sleeve gastrectomy (removing part of the stomach) with a modified version called N-Sleeve, which adds a wrap around the top of the stomach to prevent acid reflux. The trial was designed for people with severe obesity and GERD, but only 2 patients enrolled before the study was terminated. Because it stopped so early, we cannot draw any meaningful conclusions about which surgery might be better.

What this could mean

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

Active substance
surgical procedure (N-Sleeve: sleeve gastrectomy with Nissen fundoplication)
What this could lead to
If successful, the N-Sleeve technique could reduce acid reflux after weight-loss surgery, potentially improving quality of life for people with severe obesity and GERD.
What could go wrong
The trial was terminated early with only 2 participants, so no reliable conclusions can be drawn. The added procedure may also carry extra surgical 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

2 people

The number who actually took part.

Started

Sep 2022

Finished

Nov 2022

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 65 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: * Signed informed consent form * Subjects must be able to attend all scheduled visits and to comply with all trial procedures * Subjects must be covered by public health insurance * Contraception efficacy * Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH)) Exclusion Criteria: * Subject unable to read or/and write * Planned longer stay outside the region that prevents compliance with the visit plan * Current pregnancy * Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass). * BMI \> 50 kg / m² for women and \> 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases). * Barrett oesophagus and esophagitis stage III and IV. * Funditis * Long-term NSAIDs and/or corticosteroid therapy * No affiliation at the French social security scheme. * Major protected by law. * Deprivation of liberty by judicial or administrative decision. * Participation to another clinical research program.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease morbid obesity Obesity

As listed by the trial registrant

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

Bariatric surgery candidate GERD Morbid obesity Severe obesity

Contacts and locations

Locations

  • CHU Montpellier

    Montpellier, 34295, France

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