Which patients benefit most from endoscopic sleeve gastroplasty (ESG) for weight loss

Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty & Study the Evolution of Clinical, Biological and Intestinal Intestinal Microbiota After Surgery

This project will try to identify which adults with obesity (including BMI 30–35 with related complications or those unable to have bariatric surgery) lose the most weight after endoscopic sleeve gastroplasty (ESG).

Quick facts

• Study type: Observational
• Enrollment: 205 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT06153056 on ClinicalTrials.gov

What this trial studies

This is an observational study carried out at Hôpital Antoine Béclère that follows adults undergoing endoscopic sleeve gastroplasty (ESG) to identify factors linked to better weight loss outcomes. Participants provide blood, stool, and saliva samples and undergo metabolic and clinical monitoring to track weight change and biological markers over time. The investigators will analyze clinical characteristics, metabolomic profiles, and gut microbiota alongside demographic and comorbidity data to find predictors of response. Findings aim to refine patient selection and individualize care for people considering ESG.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI 30–35 kg/m² and at least one obesity-related complication, or with BMI >35 kg/m² who have been denied bariatric surgery and who have failed conventional weight-loss methods, are ideal candidates.

Not a fit: Patients who recently took antibiotics, have active gastrointestinal inflammatory disease, significant liver or renal failure, peptic ulcer disease, a need for regular endoscopic surveillance for gastric cancer risk, or those under legal protection are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the work could help select patients most likely to benefit from ESG, improving outcomes and avoiding unnecessary invasive procedures.

How similar studies have performed: Prior studies show ESG can produce meaningful weight loss, but research specifically identifying predictors of who benefits most is limited.

Eligibility criteria

Inclusion Criteria:

* Patient of legal age (Age ≥ 18 years)
* Patient capable of understanding the study and signing a consent.
* BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).
* Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.
* Patient who has failed to lose weight and improve with conventional techniques.
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient having taken antibiotics 3 months prior to inclusion.
* Patient under legal protection.
* Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.
* Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.
* Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.
* Patient with pathology affecting general health health and/or life expectancy.
* Patient with a history of bariatric surgery.
* Patient on AME

Where this trial is running

Paris

• Hôpital Antoine Béclère — Paris, France (Recruiting)

Study contacts

• Principal investigator: Cosmin VOICAN, MD, PhD — APHP, Antoine-Béclère Hospital
• Study coordinator: Cosmin VOICAN, MD, PhD

Conditions Obesity; Endoscopic sleeve gastroplasty; Weight loss