Status:
NOT_YET_RECRUITING
Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
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. Wh...
Detailed Description
The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including card...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patient having taken antibiotics 3 months prior to inclusion.
- Patient under legal protection.
- 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 pathology affecting general health health and/or life expectancy.
- Patient with a history of bariatric surgery.
- Patient on AME
Key Trial Info
Start Date :
March 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 15 2030
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06153056
Start Date
March 15 2025
End Date
August 15 2030
Last Update
January 28 2025
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