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

NCT ID: NCT03900481

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2024-05-16

Brief Summary

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

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

Conditions

Bariatric Surgery; Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vertical gastric plication

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Garrido-Pradalie

Role: STUDY_DIRECTOR

Assistance Publique- Hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2019-A00261-56

Identifier Type: OTHER

Identifier Source: secondary_id

2019-18

Identifier Type: -

Identifier Source: org_study_id