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Recruiting NCT07449520

Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)

Conditions: Obesity

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 300
Sponsor: IHU Strasbourg

Location: Hôpital Privé de Provence Aix-en-Provence

Summary

EGO-Trial is the first multicenter study in France which aims to evaluate the efficacy of Endoscopic Sleeve Gastroplasty (ESG) in patients with obesity. This project fills a critical national gap by providing real-world, multicentric data from diverse French healthcare settings, offering insight into the safety, efficacy, and variability of ESG practices across institutions The project is expected to generate robust, multicentric clinical evidence on the safety and efficacy of ESG in patients with obesity within the French healthcare context.

Eligibility Criteria

Inclusion Criteria: * Patients aged 18 to 75 years. * Patients with a Body Mass Index (BMI) ≥ 30 kg/m². * Patients who have failed non-surgical weight loss interventions (diet, exercise, pharmacological therapy). * Patients not eligible for bariatric surgery or does not wish to undergo it. * Patients who can undergo general anesthesia. * Patients who are able to participate in all aspects of the study and agree to comply with all study requirements for the entire duration of the study. * Patients who are able to fully understand the study and are willing to give their consent to participate in the study. * Patients affiliated with the French social security system. Exclusion Criteria: * Patients with contraindications to endoscopic gastroplasty * Patients with active peptic ulcer disease or significant gastroparesis * Patients with a history of bariatric, gastric, or esophageal surgery. * Patients who have started medication in the last 3 months that is known to cause weight gain. * Patients with a history of uncontrolled, poorly controlled, or suspected eating disorders or psychiatric illness. * Patients with unstable and precarious health, as determined and assessed by the investigator. * Patients who are pregnant, breastfeeding, or of childbearing age and not using effective contraception. * Patients who are currently excluded (as determined by a previous or ongoing study). * Patients under judicial protection. * Patients under guardianship, conservatorship or subject to any form of protective supervision

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07449520). StuddyBuddy aggregates publicly available trial information.