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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Adult patients (i.e., age between 18 and 70 years).

• BMI ≥ 35 kg/m²;

• Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);

• Signed informed consent.

Locations
Other Locations
Italy
Fondazione Policlinico Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Giuseppe Marrone
giuseppe.marrone@policlinicogemelli.it
+390630157779
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2024-11
Participants
Target number of participants: 24
Treatments
Experimental: Liver transplant obese candidates
Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2)
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov