Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:38 AM
Study NCT ID:
NCT07449520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Sponsor:
IHU Strasbourg
Organization:
Study Overview
Official Title:
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: