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

NCT03900481 | Terminated DMC

• 2 other identifiers: 2019-182019-A00261-56
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Bariatric Surgery; Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vertical gastric plication

EXPERIMENTAL

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

Interventions

Vertical gastric plication 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.

Vertical gastric plication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Emilie Garrido-Pradalie

  Assistance Publique- Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: September 17, 2019
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

FR (1)