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Completed

NCT Number: NCT05072067

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Du Trocadero

Paris, 75016, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the sleeve gastroplasty with the endoscopic system Overstich SX

Procedure

the sleeve gastroplasty with the endoscopic system Overstich SX

Primary outcomes

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

    Time frame: 6 MONTHS

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

    Time frame: 12 MONTHS

Secondary outcomes

  1. Evaluation of safety Immediate morbidity

    Time frame: DAY 1

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

    Time frame: 6 MONTHS

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

    Time frame: 12 MONTHS

Sponsors and collaborators

Lead sponsor

Clinique du Trocadéro

Other

Registry information

Acronym: SLEEVE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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