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New stitch procedure could help obese patients shed pounds without surgery

NCT ID NCT07449520

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a procedure called endoscopic sleeve gastroplasty (ESG) for weight loss in 300 adults with obesity. ESG uses a special device to stitch the stomach smaller from the inside, without cutting or removing any tissue. The goal is to see if it helps people lose weight safely and effectively over two years.

What this could mean

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

Active substance
endoscopic sleeve gastroplasty (a procedure that reduces stomach volume using a suture device, without cutting or removing tissue)
What this could lead to
If successful, this could provide a less invasive, effective weight-loss option for people with obesity who cannot or do not want traditional surgery.
What could go wrong
This is an early-stage, non-randomized study in France, so results may not apply everywhere. The procedure carries risks like any medical intervention, and long-term weight loss success is not guaranteed.

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

About 300 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 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.

Who is studied

Adult patients with obesity scheduled for endoscopic gastroplasty

Ages

18 to 75 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 75 years. * Patients with a Body Mass Index (BMI) ≥ 30 kg/m². * Patients who have failed non-surgical weight loss interventions (diet, exercise, pharmacological therapy). * Patients not eligible for bariatric surgery or does not wish to undergo it. * Patients who can undergo general anesthesia. * Patients who are able to participate in all aspects of the study and agree to comply with all study requirements for the entire duration of the study. * Patients who are able to fully understand the study and are willing to give their consent to participate in the study. * Patients affiliated with the French social security system. Exclusion Criteria: * Patients with contraindications to endoscopic gastroplasty * Patients with active peptic ulcer disease or significant gastroparesis * Patients with a history of bariatric, gastric, or esophageal surgery. * Patients who have started medication in the last 3 months that is known to cause weight gain. * Patients with a history of uncontrolled, poorly controlled, or suspected eating disorders or psychiatric illness. * Patients with unstable and precarious health, as determined and assessed by the investigator. * Patients who are pregnant, breastfeeding, or of childbearing age and not using effective contraception. * Patients who are currently excluded (as determined by a previous or ongoing study). * Patients under judicial protection. * Patients under guardianship, conservatorship or subject to any form of protective supervision

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

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

Obesity

How to take part

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

  1. The places running it

    10 sites in 2 countries. 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

  • Centre Mutualiste de l'Obésité

    Saint-Etienne, France

  • Clinique Clémentville

    Montpellier, France

  • Clinique les Eaux Claires

    Baie-Mahault, Guadeloupe

  • Clnique des Cèdres

    Échirolles, France

  • Hospices Civils de Lyon - Hôpital Edourard HERRIOT

    Lyon, France

  • Hôpital HURIEZ

    Lille, France

  • Hôpital Privé de Provence

    Aix-en-Provence, France

  • Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil

    Strasbourg, France

  • Polyclinique Sainte Thérèse

    Sète, France

  • Polyclinique de Franche-Comté

    Besançon, France

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