National Registry of Obesity Treatment by Endosleeve

NCT06657339 | Not Yet Recruiting

• 1 other identifier: SFED-153
• Study Type: observational
• Target: 354
• Locations: 0 countries
• Sites: N/A

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

Keywords

Endosleeve; Endoscopic gastroplasty; Endoscopic suture

Outcome Measures

Primary Outcomes (1)

• Measurement of total weight loss (TWL) in % 5 years afther endosleeve

  To determine the proportion of patients who met the PIVI criteria after endosleeve without additional techniques

  5 years

Secondary Outcomes (11)

• Measurement of total weight loss (TWL) in %

  12 et 24 months

• Measurement excess weight loss after the endosleeve intervention.

  12, 24 months, and 5 years

• Measurement of the percentage of postoperative complications according to the AGREE classification

  Day 1 and Day 30.

• Measurement of remission (or regression) of pre-existing comorbidities

  12 months, 24 months, and 5 years.

• Occurrence of metabolic comorbidities

  12 months, 24 months, and 5 years

Study Arms (1)

Endoscopic sleeve gastroplasty

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

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

Interventions

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

Endoscopic sleeve gastroplasty

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any referred patient with obesity and a BMI \> 30 kg/m² who meets the inclusion criteria and is considered suitable for therapeutic management of obesity will be invited to participate in the study at the investigating centers

You may qualify if:

• Age over 18 years;
• Patient with a body mass index (BMI) ≥ 30 kg/m²;
• Signed informed consent

You may not qualify if:

• 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;

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Endocopy, Principal Investigator, Medical doctor

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 24, 2024

Record last verified: 2024-10