Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity (SLEEVE)

The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice

Study Overview

• Status: Terminated
• Conditions: Morbid Obesity; Bariatric Surgery
• Intervention / Treatment: Procedure: Vertical gastric plication

Detailed Description

Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Sleeve gastrectomy), or malabsorptive surgery (Bypass surgery). The good medical practice guidelines recommend bariatric surgery for patients with body mass index (BMI) greater than 40 kg/m² without co-morbidities or between 35 and 40 kg/m² with co-morbidities (cardiovascular diseases, diabetes, sleep apnea, etc). Bariatric surgery is currently not an option for obese patients with a BMI between 30 and 35 kg/m² with or without comorbidities (Class I) or with a BMI between 35 and 40 kg/m² without comorbidity (Class II without comorbidity). Patients with obesity of class I, or class II without co-morbidity, currently have no possibility of interventional treatment other than nutritional therapy.

Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive. Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management (5). Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.

The investigators wish to carry out a bi-centric pilot study (Marseille, Nice) which will validate the effectiveness (in terms of excess weight loss and total body weight loss) of this new endoscopic technique for patients previously excluded from any surgical management of their obesity (class I, or class II without comorbidity). The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years ≤ age ≤ 65 years
• Class I obesity (30 <BMI <35 kg / m²) or Class II without comorbidity (35 <BMI <40 kg / m²)

Exclusion Criteria:

• Achalasia or other disturbance of motility of the esophagus;
• severe esophagitis;
• Peptic ulcer disease;* uncontrolled diabetes
• Weight loss> 5% of the total weight over the last 6 months;
• Gastrointestinal stenosis or obstruction;
• Pregnancy, breastfeeding, or desire for pregnancy in the next 18 months;
• Previous bariatric surgery, balloon or other endoscopic therapy of obesity;
• Gastric surgery scheduled within 60 days of surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Vertical gastric plication; Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive

Procedure: Vertical gastric plication; Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the excess weight loss	Measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Emilie Garrido-Pradalie, Assistance Publique- Hôpitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2019-18 (Other Identifier: Gemini Eye Clinics); 2019-A00261-56 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No