Obesity
Conditions
Keywords
Obesity, Endoscopic Sleeve Gastroplasty, Excess weight loss, Body Mass Index, Quality of Life
Brief 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.
Detailed description
Obesity, particularly morbid obesity, is a major public health issue in France. According to the latest data from the ObÉpi-Roche 2020 survey, more than 17% of French adults are obese. Obesity is a well-established risk factor for many chronic diseases such as type 2 diabetes, cardiovascular disease, high blood pressure (HBP), musculoskeletal disorders, certain cancers, and non-alcoholic steatohepatitis (NASH). It is associated with a significant reduction in life expectancy and represents a direct cost estimated at more than €5 billion per year for the French healthcare system. While bariatric surgery (particularly sleeve gastrectomy and gastric bypass) remains the gold standard treatment for severe obesity, it is invasive, costly, and only offered to a minority of patients (less than 10% of eligible patients). In addition, certain medical contraindications, refusal of surgery, and waiting times limit access to this treatment. Endoscopic sleeve gastroplasty ("Endosleeve"). Endoscopic sleeve gastroplasty (ESG) is an innovative, non-surgical, natural procedure that reduces stomach volume without resection or anastomosis. It has shown promising results in terms of weight loss, metabolic improvement, and safety, while being reversible and reproducible. The MERIT randomized controlled trial in USA (JAMA, 2022) demonstrated an average weight loss of 13.6% of total body weight at 12 months (vs. 0.8% in the control group), as well as a significant improvement in comorbidities such as type 2 diabetes and hypertension. Hypothesis and objective of the study The hypothesis of this study is that ESG, when performed under routine care conditions in the United States, leads to significant and sustainable weight loss, associated with an improvement in comorbidities, with a favorable safety profile. The main objective of this project is therefore to evaluate, on a national scale, the clinical efficacy, safety, and procedural variability of ESG through a multicenter real-world cohort. To date, no large-scale French study has analyzed the results of ESG in real-world settings. This hinders its integration into national healthcare pathways, its reimbursement by the French national health insurance system, and its wider adoption by the medical community. The question raised-the rigorous evaluation of ESG in the French context-therefore remains unanswered. This project aims to generate robust data representative of the national clinical reality in order to support the supervised development of ESG. Expected outcomes include the publication of scientific articles in peer-reviewed journals, the presentation of results at international conferences, contributions to health technology assessment work, and the establishment of a national registry of endoscopic gastroplasty. This work could represent a major advance in the therapeutic arsenal for obesity, supporting the integration of ESG as a recognized, validated, and reimbursed option in French healthcare pathways.
Interventions
PROCEDUREEndoscopic 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
Sponsors
IHU Strasbourg
SOFF.COMM
Boston Scientific International S.A.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excess weight loss | At the inclusion and 24 months after procedure | Assessment of weight loss in terms of excess weight loss (EWL, %) at 24 months post-procedure |
| Body Mass Index (BMI) | From ESG procedure to the end of participation at 24 months post-procedure | Assessment of weight loss in terms of change in Body Mass Index (BMI) at 24 months post-procedure |
| Adverse events | From ESG procedure to the end of participation at 24 months post-procedure | Rate of minor and major adverse events (e.g., perforation, delayed gastric emptying, reflux symptoms) throughout follow-up for up to 24 months post-procedure |
| Comorbidities improvement | From ESG procedure to the end of participation at 24 months post-procedure | Assessment of improvement in comorbidities (type 2 diabetes, hypertension, dyslipidemia, sleep apnea) and obesity-related complications over 24 months using the SF-BARI (Swiss-Finnish BARIatric metabolic outcome score) questionnaire: a score developed to evaluate treatment outcomes in obesity management |
| Quality of life improvement | From ESG procedure to the end of participation at 24 months post-procedure | Assessment of quality of life over 24 months using the GIQLI (Gastrointestinal Quality of Life Index) questionnaire: digestive quality of life score comprising 36 items relating to symptoms, physical status, emotions, social problems, and the effect of medical treatments |
| Additional treatments | From ESG procedure to the end of participation at 24 months post-procedure | Compilation of additional treatments or revisions required after the procedure |
Countries
France, Guadeloupe
Contacts
CONTACTArmelle TAKEDA
CONTACTClinical Research Team
PRINCIPAL_INVESTIGATORSilvana PERRETTA, MD-PhD
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed