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

NCT07449520 | Not Yet Recruiting

• 1 other identifier: 25-004
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 10

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.

Conditions

Obesity

Keywords

Obesity; Endoscopic Sleeve Gastroplasty; Excess weight loss; Body Mass Index; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Total Body Weight Loss

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

  At the inclusion and 24 months after procedure

Secondary Outcomes (6)

• Excess weight loss

  At the inclusion and 24 months after procedure

• Body Mass Index (BMI)

  From ESG procedure to the end of participation at 24 months post-procedure

• Adverse events

  From ESG procedure to the end of participation at 24 months post-procedure

• Comorbidities improvement

  From ESG procedure to the end of participation at 24 months post-procedure

• Quality of life improvement

  From ESG procedure to the end of participation at 24 months post-procedure

Study Arms (1)

All adult patients with obesity scheduled for endoscopic gastroplasty (ESG)

Procedure: Endoscopic sleeve gastroplasty

Interventions

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

All adult patients with obesity scheduled for endoscopic gastroplasty (ESG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with obesity scheduled for endoscopic gastroplasty

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific International S.A.: collaborator
• IHU Strasbourg: lead
• SOFF.COMM: collaborator

Study Sites (10)

Hôpital Privé de Provence

Aix-en-Provence, France

Location

Polyclinique de Franche-Comté

Besançon, France

Location

Clnique des Cèdres

Échirolles, France

Location

Hôpital HURIEZ

Lille, France

Location

Hospices Civils de Lyon - Hôpital Edourard HERRIOT

Lyon, France

Location

Clinique Clémentville

Montpellier, France

Location

Centre Mutualiste de l'Obésité

Saint-Etienne, France

Location

Polyclinique Sainte Thérèse

Sète, France

Location

Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil

Strasbourg, France

Location

Clinique les Eaux Claires

Baie-Mahault, Guadeloupe

Location

Related Links

• Institut de Recherche et Documentation en Économie de la Santé (IRDES). Coût des pathologies liées à l'obésité. Études et résultats, 2021.
• Haute Autorité de Santé (HAS). Guide du parcours de soins : surpoids et obésité de l'adulte.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvana PERRETTA, MD-PhD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armelle TAKEDA

CONTACT

0033 390 413608; armelle.takeda@ihu-strasbourg.eu

Clinical Research Team

CONTACT

rc-ihu@ihu-strasbourg.eu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9); GU (1)