Gastric Recalibration After Endoscopic Sleeve Gastroplasty

Recruiting now · Not applicable

Conditions studied: Morbid Obesity

In brief

Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.

Key facts

Study ID

NCT04945473

Run by

IHU Strasbourg

People needed

100

Starts

2021-07-13

Expected to finish

2026-09-01

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Service de chirurgie digestive et endocrinienne, NHC — Strasbourg, France (enrolling)

Full record on ClinicalTrials.gov

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