Gastric recalibration after endoscopic sleeve gastroplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of endoscopic sleeve gastroplasty (ESG) as a treatment for morbid obesity, focusing on the potential benefits of performing a revision procedure during follow-up endoscopy. ESG is a minimally invasive technique that reduces the size of the stomach using sutures, offering a reversible alternative to traditional bariatric surgery. The study aims to assess the impact of additional sutures on weight loss and improvement of obesity-related comorbidities in patients who have not achieved significant weight loss. Participants will be monitored for changes in their condition and overall health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18 to 75
* Patients with morbid obesity (BMI≥ 30 with comorbidities or\> 40)
* Patients with obesity for more than 2 years
* Failure of medical treatment of obesity
* Patients who may benefit from general anaesthesia
* Patient able to participate in all aspects of the study and that agree to comply with all study requirements, for the duration of the study. This includes the availability of reliable transportation and sufficient time to attend all follow-up visits.
* Patient able to fully understand the study and ready to give consent to participate to the study.
* Patient affiliated to the French social security system

Exclusion Criteria:

* Patient with a contraindication to perform an ESG
* Patient with a history of previous bariatric, gastric or esophageal surgery.
* Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
* Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
* Patient with unstable and precarious state of health, as determined and assessed by the investigator.
* Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
* Patient in exclusion period (determined by a previous or ongoing study)
* Patient under legal protection
* Patient under guardianship or curatorship
* Patients with a BMI less than 30 at 6 months after ESG. These patients will not be candidate for revision regardless of the randomization group.
* Patients with a contraindication to MRI may be included in the study and will follow the "No Imaging" study design.

Where it's running

• Service de chirurgie digestive et endocrinienne, NHC
  Strasbourg, France Recruiting

Study contacts

• Principal investigator: Silvana PERRETTA, MD, PHD — Service de chirurgie digestive et endocrinienne, NHC, Strasbourg
• Study coordinator: Pierre GOEPFERT
• Email: pierre.goepfert@ihu-strasbourg.eu
• Phone: 0390413646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.