Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty
Recruiting · NCT06153056 · Observational (researchers observe without assigning treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Hôpital Antoine Béclère - Paris, France