Gastric recalibration after endoscopic sleeve gastroplasty
Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients
This study is testing if adding extra stitches during a follow-up procedure after endoscopic sleeve gastroplasty can help people with severe obesity lose more weight and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IHU Strasbourg Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04945473 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with morbid obesity (BMI≥30 with comorbidities or >40) who have not achieved significant weight loss after previous treatments.
Not a fit: Patients who have had previous bariatric, gastric, or esophageal surgery or those with contraindications to ESG will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and reversible option for patients struggling with morbid obesity, potentially leading to improved weight loss and health outcomes.
How similar studies have performed: While there is limited data on the effectiveness of endoscopic revisions, this approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Strasbourg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.