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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
the sleeve gastroplasty with the endoscopic system Overstich SX
Sponsored by
Clinique du Trocadéro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Du Trocadero

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OBESE PATIENT

Arm Description

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

Outcomes

Primary Outcome Measures

For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost

Secondary Outcome Measures

Evaluation of safety Immediate morbidity
For sleeve revision, by the rate of patients with a percentage of total weight lost
For sleeve revision, by the rate of patients with a percentage of total weight lost

Full Information

First Posted
September 28, 2021
Last Updated
September 26, 2023
Sponsor
Clinique du Trocadéro
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1. Study Identification

Unique Protocol Identification Number
NCT05072067
Brief Title
EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
September 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique du Trocadéro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OBESE PATIENT
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
the sleeve gastroplasty with the endoscopic system Overstich SX
Intervention Description
the sleeve gastroplasty with the endoscopic system Overstich SX
Primary Outcome Measure Information:
Title
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
Time Frame
6 MONTHS
Title
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
Evaluation of safety Immediate morbidity
Time Frame
DAY 1
Title
For sleeve revision, by the rate of patients with a percentage of total weight lost
Time Frame
6 MONTHS
Title
For sleeve revision, by the rate of patients with a percentage of total weight lost
Time Frame
12 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinique Du Trocadero
City
Paris
ZIP/Postal Code
75016
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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