Actively Recruiting

Age: 18Years +
All Genders
NCT06153056

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-21

205

Participants Needed

1

Research Sites

281 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient of legal age (Age 218 years)
  • Patient capable of understanding the study and signing a consent
  • BMI between 30 and 35 kg/m2 with at least one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain)
  • Patients with BMI greater than 35 kg/m2 who have been refused bariatric surgery
  • Patient who has failed to lose weight and improve with conventional techniques
  • Patient affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Patient having taken antibiotics 3 months prior to inclusion
  • Patient under legal protection
  • Patient at risk of gastric cancer requiring regular endoscopic surveillance
  • Patient with history of gastrointestinal inflammatory disease, hepatic or renal insufficiency, or portal hypertension
  • Patient with peptic ulcer disease or progressive peptic ulcer disease
  • Patient with pathology affecting general health and/or life expectancy
  • Patient with history of bariatric surgery
  • Patient on AME

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Antoine Béclère

Paris, France

Actively Recruiting

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Research Team

C

Cosmin VOICAN, MD, PhD

CONTACT

G

Gabriel PERLEMUTER, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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