National Registry of Obesity Treatment by Endosleeve

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)

• Study Type: Observational
• Enrollment (Estimated): 354

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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™); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of total weight loss (TWL) in %	Determine total weight loss (TWL) afther endosleeve at 12, 24 months,	12 et 24 months
Measurement excess weight loss after the endosleeve intervention.	Determine excess weight loss (EWL) after the endosleeve intervention, with positivity established by the PIVI criteria (EWL > 25% at 12 months), and evaluate the long-term evolution of this EWL	12, 24 months, and 5 years
Measurement of the percentage of postoperative complications according to the AGREE classification	The safety of this procedure will be evaluated by recording complications perioperatively (Day 1) and post-procedure (Day 30) according to the AGREE criteria and using the PIVI criteria (positive if the complication rate is < 5%).	Day 1 and Day 30.
Measurement of remission (or regression) of pre-existing comorbidities	Determine the impact on pre-existing metabolic comorbidities : Diabetes remission = HbA1C < 6.5%, 3 months after discontinuation of all treatment / Regression or improvement of diabetes involving a decrease of more than 0.5% in HbA1C according to recognized criteria; Hypertension = Systolic blood pressure (SBP) < 140 mmHg and/or Diastolic blood pressure (DBP) < 90 mmHg without any treatment / Decrease in the number of therapeutic classes;; Obstructive Sleep Apnea Syndrome (OSAS) = Number of apneas less than 5 without equipment / Decrease in OSAS stage = mild (5 to 15 per hour), moderate (15 to 30), or severe (more than 30) with or without equipment;; Steatohepatitis = quantification by MRI of the % of fat in the liver with a decrease of more than 30%;; Dyslipidemia = normalization or improvement of LDL cholesterol and triglyceride levels without the addition of new drug therapies.	12 months, 24 months, and 5 years.
Occurrence of metabolic comorbidities	The occurrence of metabolic comorbidities such as diabetes, hypertension (HTN), obstructive sleep apnea syndrome (OSAS), steatohepatitis, and dyslipidemia will be assessed at 12, 24 months, and at the end of the follow-up period. Each comorbidity will be evaluated according to its specific definitional criteria	12 months, 24 months, and 5 years
Outpatient procedures	Number of outpatient procedures performed without the need for readmission within 30 days of follow-up	30 days
Bariatric procedures performed following the initial intervention	Number and type of bariatric procedures performed following the initial intervention (Redo EndoSleeve, medication treatment such as GLP-1 agonists or equivalent, instrumental treatment with a balloon or other methods)	Day 1 and Day 30.
Conversion rates in bariatric surgery and their feasibility	Number of conversions to bariatric surgery (Sleeve and bypass) and their feasibility (whether the procedure was possible)	3 years and 5 years
Predictive factors for response, weight regain, and plateau at the EndoSleeve	Determination of predictive factors for response, failure (<5% total weight loss at 6 months), weight regain (50% of the lost weight regained at or after one year), and plateau with EndoSleeve (≥10% weight loss but no further loss for more than 3 months)	3 months, 6 months and 1 year
Sequence of bariatric procedures that led to the best weight response	Description of the sequence of bariatric procedures leading to the best weight loss outcome after 5 years of follow-up	5 years
Measurement of the improvement in quality of life.	Impact on quality of life will be measured through quality of life questionnaires (BAROS questionnaire) before the intervention and during each medical visit, to assess psychological health before and after the intervention.	12 months , 24 months, and at 5 years of follow-up.

Collaborators and Investigators

• Sponsor: Société Française d'Endoscopie Digestive

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic gastroplasty; Endosleeve; Endoscopic suture
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: SFED-153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No