Adding Stitches During Endoscopic Stomach Reshaping for Obesity
Tests extra endoscopic stitches to tighten the stomach after sleeve gastroplasty in adults with obesity.
Plain-language title generated from the registry record
Registry title: Gastric Recalibration After Endoscopic Sleeve Gastroplasty
Key facts
- Where
- Strasbourg, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04945473, who can take part
Where in France
- Service de Chirurgie Digestive et Endocrinienne, NHCStrasbourg, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IHU Strasbourg
- Trial code
- NCT04945473
- Record updated
- 1 May 2025
- Original description
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.Read full original descriptionShow less
Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients
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.
Inclusion: 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: 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 in exclusion period (determined by a previous or ongoing study); Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness; Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception; Patient with a contraindication to perform an ESG; Patient with unstable and precarious state of health, as determined and assessed by the investigator; 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.