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

Obesity Clinical Trial

— SLEEVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072067
• Other study ID #: 2021-A01562-39
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: September 2023
• Source: Clinique du Trocadéro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 26, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Procedure:
• the sleeve gastroplasty with the endoscopic system Overstich SX
the sleeve gastroplasty with the endoscopic system Overstich SX

Locations

Country	Name	City	State
France	Clinique Du Trocadero	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinique du Trocadéro

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost		6 MONTHS
Primary	For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost		12 MONTHS
Secondary	Evaluation of safety Immediate morbidity		DAY 1
Secondary	For sleeve revision, by the rate of patients with a percentage of total weight lost		6 MONTHS
Secondary	For sleeve revision, by the rate of patients with a percentage of total weight lost		12 MONTHS