National Registry of Obesity Treatment by Endosleeve

NCT ID: NCT06657339

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 354 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2029-12-31

Brief Summary

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.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic sleeve gastroplasty

Therapeutic endoscopy using a gastric suturing device (OverStitch™/Endomina™) according to the practices of the investigating center

Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)

Intervention Type: PROCEDURE

The patient will undergo therapeutic endoscopy under general anesthesia, either as outpatient or inpatient care, based on the recommendations of the investigating physician, taking into account anesthetic risks and comorbidities. Two CE-marked gastric suturing devices may be used at the discretion of the investigating center based on their practices

OverStich™ allows for tissue fixation via a gastroscope, creating a durable suture through a transabdominal fixation technique. The procedure lasts about 45 minutes and includes measures to prevent vomiting.

Endomina™ is a single-use device that captures the gastric mucosa to create successive plications, allowing for effective suturing along the greater curvature of the stomach.

Interventions

Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)

The patient will undergo therapeutic endoscopy under general anesthesia, either as outpatient or inpatient care, based on the recommendations of the investigating physician, taking into account anesthetic risks and comorbidities. Two CE-marked gastric suturing devices may be used at the discretion of the investigating center based on their practices

OverStich™ allows for tissue fixation via a gastroscope, creating a durable suture through a transabdominal fixation technique. The procedure lasts about 45 minutes and includes measures to prevent vomiting.

Endomina™ is a single-use device that captures the gastric mucosa to create successive plications, allowing for effective suturing along the greater curvature of the stomach.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française d'Endoscopie Digestive

OTHER

Sponsor Role: lead

Responsible Party

VANBIERVLIET

Director, Head of Endocopy, Principal Investigator, Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SFED-153

Identifier Type: -

Identifier Source: org_study_id