Clinical trial

Gastric Recalibration After Endoscopic Sleeve Gastroplasty

Recruiting now · Not applicable · 1 countries · Registry ID NCT04945473

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionMorbid Obesity

Full registry criteria

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.

Treatments and study arms

Endoscopic placement of additional sutures

Procedure

A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.

Primary outcomes

Total weight loss (TWL)3, 6, 12, 18 and 24 months after the ESG

The primary endpoint is the assessment of weight evolution in terms of total weight loss (TWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the TWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Service de chirurgie digestive et endocrinienne, NHC🇫🇷 Strasbourg, France
Silvana PERRETTA, MD, PHDContact