EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS (SLEEVE)

The OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. The OverStitch ™ Sx allows suturing in the upper and lower GI with a flexible single channel endoscope. Previously, the ™ Overstich was only compatible with an Olympus dual channel endoscope.

Thus, a wide range of interventions are possible, including gastric endoplastic sleeve (ESG), RYGB revision, anastomotic fistula repair and / or sleeve revision. In each of these indications, the OverStitch (OverStitch) ™ system has shown its effectiveness and safety.

The OverStitch Endoscopic ™ Suture System allows the entire digestive wall to be sutured through a flexible endoscope. Thus, a wide range of interventions are possible, including gastric pocket repair after gastric bypass surgery, anastomotic fistula repair, endoscopic treatment of digestive perforation, and endoscopic sleeve surgery. In each of these indications, the OverStitch system has demonstrated its effectiveness and safety. But this technique is recent, especially in France. In addition, no data has yet been released regarding the new Overstitch ™ Sx device compatible with all single channel endoscopes.

An observational study including patients in French centers that are experts in therapeutic endoscopy seems essential to us to better assess this new device and this new technique in practice

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: the sleeve gastroplasty with the endoscopic system Overstich SX

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75016
    • Clinique du Trocadero

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient over 18, male or female
• Patient with obesity with a BMI> 30 or BMI> 40 (if surgery contraindicated or refused by the patient)
• Patient with a weight gain after sleeve gastroplasty or sleeve gastrectomy
• Informed and written consent of the patient obtained
• Complete clinical examination
• Lack of participation in another clinical study
• Patient able to follow, understand the study and answer the questionnaire

Exclusion Criteria:

• Haemorrhagic disease, haemostasis and coagulation disorder and platelets <60000 / mm3).
• Breastfeeding women
• Toxicomany, alcoolism
• Patient known for gastric lesion requiring surveillance or familial history of gastric neoplasia
• Hiatus hernia> 4 cm high

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: OBESE PATIENT; OverStitch™ Sx with a Single channel endoscop CO2 Insufflation, patient on decubitus dorsal, with intubate 3 to 7 sutures, from the antral ogiv to the cardia are done	Procedure: the sleeve gastroplasty with the endoscopic system Overstich SX; the sleeve gastroplasty with the endoscopic system Overstich SX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost	6 MONTHS
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost	12 MONTHS

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of safety Immediate morbidity	DAY 1
For sleeve revision, by the rate of patients with a percentage of total weight lost	6 MONTHS
For sleeve revision, by the rate of patients with a percentage of total weight lost	12 MONTHS

Collaborators and Investigators

• Sponsor: Clinique du Trocadéro

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2021-A01562-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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