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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: the sleeve gastroplasty with the endoscopic system Overstich SX

• Registration Number: NCT05072067
• Lead Sponsor: Clinique du Trocadéro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-08
• Study Start: 2021-10-14
• Primary Completion: 2023-06-30
• Status Verified: 2023-09
• Study Completion: 2023-09-26
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OBESE PATIENT	the sleeve gastroplasty with the endoscopic system Overstich SX	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

Primary Outcome Measures

Name	Time	Method
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost	12 MONTHS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Du Trocadero; 🇫🇷 Paris, France