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

NCT05072067 | Completed

• 1 other identifier: 2021-A01562-39
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

OBESE PATIENT

EXPERIMENTAL

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

Interventions

the sleeve gastroplasty with the endoscopic system Overstich SX PROCEDURE

the sleeve gastroplasty with the endoscopic system Overstich SX

OBESE PATIENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique du Trocadéro: lead

Study Sites (1)

Clinique Du Trocadero

Paris, 75016, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: October 14, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 26, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)