An observational study in Obesity, sponsored by IHU Strasbourg. Recruiting at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by IHU Strasbourg · Observational
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →IHU Strasbourg is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with obesity scheduled for endoscopic gastroplasty
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: 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
Total Body Weight Loss
Assessment of weight loss in terms of total body weight loss (TBWL, %) 24 months after surgery
Time frame: At the inclusion and 24 months after procedure
Excess weight loss
Assessment of weight loss in terms of excess weight loss (EWL, %) at 24 months post-procedure
Time frame: At the inclusion and 24 months after procedure
Body Mass Index (BMI)
Assessment of weight loss in terms of change in Body Mass Index (BMI) at 24 months post-procedure
Time frame: From ESG procedure to the end of participation at 24 months post-procedure
Adverse events
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
Time frame: From ESG procedure to the end of participation at 24 months post-procedure
Comorbidities improvement
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
Time frame: From ESG procedure to the end of participation at 24 months post-procedure
Quality of life improvement
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
Time frame: From ESG procedure to the end of participation at 24 months post-procedure
Additional treatments
Compilation of additional treatments or revisions required after the procedure
Time frame: From ESG procedure to the end of participation at 24 months post-procedure
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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