National Registry of Obesity Treatment by Endosleeve

Launched by SOCIÉTÉ FRANÇAISE D'ENDOSCOPIE DIGESTIVE · Oct 21, 2024

Keywords

ClinConnect Summary

The National Registry of Obesity Treatment by Endosleeve is a clinical trial that aims to study the long-term effectiveness and safety of a new, less invasive treatment for obesity called the endosleeve. Obesity is a serious health issue that affects many people and can lead to various medical problems. While traditional surgical options like gastric banding and sleeve gastrectomy are effective, the endosleeve offers a potential alternative that respects the body's anatomy and may be less risky and costly. This trial will collect data from patients being treated at specialized obesity centers to help determine if the endosleeve can become a standard treatment option.

To participate in this trial, individuals must be over 18 years old and have a body mass index (BMI) of 30 or higher, which indicates obesity. However, certain health conditions, like previous gastrointestinal surgeries or severe mental health issues, may prevent someone from joining the study. Participants will need to sign a consent form and can expect to receive care and monitoring as part of the trial. The information gathered will be crucial in evaluating the endosleeve as a viable long-term solution for managing obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age over 18 years;
• • Patient with a body mass index (BMI) ≥ 30 kg/m²;
• • Signed informed consent
• Exclusion Criteria:
• • Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
• • Presence of an ulcer in the gastric body or fundus;
• • Achalasia, severe esophagitis (Los Angeles grade C or D);
• • ENT or esophageal malformation;
• • Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
• • Congestive gastropathy, gastric polyposis, gastric or esophageal varices, risk of gastric tumor disease due to personal or family history;
• • Positive Helicobacter pylori status with failed eradication treatments;
• • Uncontrolled or severe eating disorder or psychiatric illness;
• • Substance abuse or chronic alcoholism;
• • Severe renal insufficiency (stage 4 or 5), Cirrhosis Child B or C;
• • Anticoagulant or antiplatelet treatment that cannot be stopped or replaced according to international recommendations (ESGE 2021);
• • Coagulation or hemostasis disorders (PT \< 60%, platelets \< 60,000/mm³);
• • 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.