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NCT06153056Recruiting

Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty

Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty & Study the Evolution of Clinical, Biological and Intestinal Intestinal Microbiota After Surgery

Source: ClinicalTrials.gov · Last updated 21 Jan 2026

Brief summary (registry, in English)

Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. What's more, the French National Authority for Health recommends this procedure for patients with a BMI above 35 kg/m² with associated co-morbidities, or above 40 kg/m². This excludes grade I obese patients (30 \< BMI \< 35) who have no effective means of losing weight. The hospital's hepato-gastroenterology and nutrition department has therefore implemented endoscopic sleeve gastroplasty to address this problem. As with other surgical techniques, there is heterogeneity heterogeneity in weight loss. The investigators therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.

Status (registry)
Recruiting
Study type
Observational
Enrollment
205 (estimated)
First submitted
22 Nov 2023
Start date
9 Sept 2025
Primary completion date
2 Feb 2031
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Obesity
NCT number
NCT06153056

What you commit to

  • Study type: Observational
  • Planned participants: 205
  • From 9 Sept 2025 to the primary completion date, 2 Feb 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient having taken antibiotics 3 months prior to inclusion.

Other illness

  • Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.
  • Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.
  • Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.
  • Patient with a history of bariatric surgery.

Other

  • Patient under legal protection.
  • Patient with pathology affecting general health health and/or life expectancy.
  • Patient on AME

Who the study is looking for

  • Patient of legal age (Age ≥ 18 years)
  • Patient capable of understanding the study and signing a consent.
  • BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).
  • Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.
  • Patient who has failed to lose weight and improve with conventional techniques.
  • Patient affiliated to a social security scheme

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Antoine Béclère
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.