Stomach stitch trial for weight regain halted early
NCT ID NCT02048033
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a procedure called endoscopic suturing (using the OverStitch device) to narrow the stomach opening in people who regained weight after gastric bypass surgery. The goal was to see if this minimally invasive stitch could help them lose weight again compared to standard care. The trial was terminated early, so we have limited data on how well it worked or its long-term effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endoscopic suturing device (OverStitch)
- What this could lead to
- If it had worked, this could offer a less invasive way to help people who regain weight after gastric bypass, potentially avoiding repeat surgery.
- What could go wrong
- The trial was terminated early, so results are limited. The procedure carries risks like bleeding or injury, and it may not provide lasting weight loss.
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
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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
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74 people
The number who actually took part.
- Started
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Jan 2014
- Finished
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Apr 2017
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Age \> 18 years * Surgical criteria: patient with bariatric surgery by gastric bypass since, at least, 24 months * Clinics criteria of weight regain or treatment failure: * Patient with weight regain\> 5kg / m² * Patient with EWL (excess weight loss) \<25% after 2 years of treatment. * Loss of early satiety (interrogation) * Patient with a compatible psychological and cognitive status with the study, * Patient agreeing to follow the procedures of the study and can participate at the follow-up study during 2 years * Subject with no rights from the national health insurance programme * Consent form signed Exclusion criteria: * Pregnancy (plasma assay of beta-HCG positive) * Presence of cardiovascular, neurological, psychiatric, endocrine, renal, gastrointestinal or tumor comorbidities making irrelevant patient participation in the judgment of the investigator * Patient participating in another clinical study or participated in another study within the last 30 days or for which the annual compensation received exceeds € 4,500 * Patient with a contre-indication to the achievement of surgery (fistula, ulceration, ...)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HEGP Hospital
Paris, 75015, France
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Lille Hospital
Lille, France
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Louis Mourier Hospital
Colombes, 92700, France
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Montpellier Hospital
Montpellier, 34000, France
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Nice Hospital
Nice, 06000, France
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Strasbourg Hospital
Strasbourg, 67000, France
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Villeurbanne clinic
Villeurbanne, 69000, France