Endoscopic sleeve gastroplasty: Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device which allows for a reduction in stomach volume without resection or anastomosis
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Total Body Weight Loss — At the inclusion and 24 months after procedure Assessment of weight loss in terms of total body weight loss (TBWL, %) 24 months after surgery
Trial sites (10)
Facility
City
Region
Status
Hôpital Privé de Provence
Aix-en-Provence
France
Polyclinique de Franche-Comté
Besançon
France
Clnique des Cèdres
Échirolles
France
Hôpital HURIEZ
Lille
France
Hospices Civils de Lyon - Hôpital Edourard HERRIOT
Lyon
France
Clinique Clémentville
Montpellier
France
Centre Mutualiste de l'Obésité
Saint-Etienne
France
Polyclinique Sainte Thérèse
Sète
France
Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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