NCT04945473Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Jun 2021
- Start date
- 13 Jul 2021
- Primary completion date
- Sept 2026
- Lead sponsor
- IHU Strasbourg
- Diseases
- Obesity
- NCT number
- NCT04945473
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 13 Jul 2021 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
Age
- Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne, NHC Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.