NCT05760235

Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question\[s\] it aims to answer are: * Is the procedure effective in reducing BMI to the target level in 12 months? * Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation

Conditions

• Liver Transplantation
• Obesity
• Bariatric Surgery

Interventions

Type	Name	Description
PROCEDURE	Endoscopic sleeve gastroplasty (ESG)	ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free15. The procedure will be performed with the patient in supine position. Carbon dioxide will be blown to stretch the gastric lumen. An initial endoscopic evaluation will be performed immediately to confirm the absence of any contraindication to ESG before suturing. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch.

Timeline

• Start date: 2022-10-13
• Primary completion: 2024-10-01
• Completion: 2024-11-01
• First posted: 2023-03-08
• Last updated: 2024-03-05

Locations

1 site across 1 country: Italy