NCT06657339Not yet recruiting
National Registry of Obesity Treatment by Endosleeve
Source: ClinicalTrials.gov · Last updated 24 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Currently, the prevention of obesity in our Western societies is not effective enough, as the prevalence and incidence of obesity and overweight continue to rise worldwide. In France, the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity, with three authorized methods that have shown sufficient evidence: gastric banding, sleeve gastrectomy (or longitudinal sleeve gastrectomy), and Roux-en-Y gastric bypass. With the advent of organ-preserving interventional endoscopy, the systematic use of these surgical methods, although effective for total weight loss and excess weight loss, raises questions. Indeed, these new therapeutic endoscopic approaches, which are less invasive, less costly, and respectful of anatomy, currently show convincing cohort results in the short term (12 to 24 months) and require confirmation of their effectiveness and safety in the long term (5 years) so that they can become first-line therapeutic methods in the near future. At the request of the HAS in its self-referral of 2020 and then in 2022, this prospective registry aims to confirm the effectiveness and safety of the endosleeve (or endoscopic sleeve) in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 354 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- Dec 2024
- Primary completion date
- Dec 2029
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Diseases
- Obesity
- NCT number
- NCT06657339
What you commit to
- Study type: Observational
- Planned participants: 354
- From Dec 2024 to the primary completion date, Dec 2029
- No sites listed in no 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
- Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
Other illness
- Presence of an ulcer in the gastric body or fundus;
- Congestive gastropathy, gastric polyposis, gastric or esophageal varices, risk of gastric tumor disease due to personal or family history;
- Uncontrolled or severe eating disorder or psychiatric illness;
- Severe renal insufficiency (stage 4 or 5), Cirrhosis Child B or C;
Lab values
- Coagulation or hemostasis disorders (PT \< 60%, platelets \< 60,000/mm³);
Other
- Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
- Achalasia, severe esophagitis (Los Angeles grade C or D);
- ENT or esophageal malformation;
- Positive Helicobacter pylori status with failed eradication treatments;
- Substance abuse or chronic alcoholism;
- Anticoagulant or antiplatelet treatment that cannot be stopped or replaced according to international recommendations (ESGE 2021);
- Mental deficiency of the subject making participation in the trial impossible;
- Patient not affiliated with a social security scheme;
- Pregnant women, breastfeeding individuals;
- Inability to understand or sign the informed consent.
Who the study is looking for
- Age over 18 years;
- Patient with a body mass index (BMI) ≥ 30 kg/m²;
- Signed informed consent
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.