Clinical trial NCT05072067: EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS
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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Clinique du Trocadéro
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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

Primary outcomes:
measure: For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
timeFrame: 6 MONTHS
measure: For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Evaluation of safety Immediate morbidity
timeFrame: DAY 1
measure: For sleeve revision, by the rate of patients with a percentage of total weight lost
timeFrame: 6 MONTHS
measure: For sleeve revision, by the rate of patients with a percentage of total weight lost
timeFrame: 12 MONTHS
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Du Trocadero
Study officials:
References: