Clinical trial

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

Opening soon · Not applicable · 2 countries · Registry ID NCT07449520

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

Endoscopic sleeve gastroplasty

Procedure

Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device which allows for a reduction in stomach volume without resection or anastomosis

Primary outcomes

Total Body Weight LossAt the inclusion and 24 months after procedure

Assessment of weight loss in terms of total body weight loss (TBWL, %) 24 months after surgery

Study locations

10 locations were listed when this page was built. The first 40 are shown.

Hôpital Privé de Provence🇫🇷 Aix-en-Provence, France
Hugues SEBBAGContact
Polyclinique de Franche-Comté🇫🇷 Besançon, France
Henry-Alexis MERCOLIContact
Hôpital HURIEZ🇫🇷 Lille, France
Robert CAIAZZOContact
Hospices Civils de Lyon - Hôpital Edourard HERRIOT🇫🇷 Lyon, France
Maud ROBERTContact
Clinique Clémentville🇫🇷 Montpellier, France
Marta SILVESTRIContact
Centre Mutualiste de l'Obésité🇫🇷 Saint-Etienne, France
Pierre BLANCContact
Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil🇫🇷 Strasbourg, France
Silvana PERRETTAContact
Polyclinique Sainte Thérèse🇫🇷 Sète, France
Thibaut COSTEContact
Clnique des Cèdres🇫🇷 Échirolles, France
Fabien STENARDContact
Clinique les Eaux Claires🌐 Baie-Mahault, Guadeloupe
Venetia AVENDANOContact