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

Sponsor
Clinique du Trocadéro (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05072067
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: the sleeve gastroplasty with the endoscopic system Overstich SX
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost [6 MONTHS]

  2. For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost [12 MONTHS]

Secondary Outcome Measures

  1. Evaluation of safety Immediate morbidity [DAY 1]

  2. For sleeve revision, by the rate of patients with a percentage of total weight lost [6 MONTHS]

  3. For sleeve revision, by the rate of patients with a percentage of total weight lost [12 MONTHS]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Clinique Du TrocaderoParisFrance75016

Sponsors and Collaborators

  • Clinique du Trocadéro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinique du Trocadéro
ClinicalTrials.gov Identifier:
NCT05072067
Other Study ID Numbers:
  • 2021-A01562-39
First Posted:
Oct 8, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021