Pilot Study of Endoscopic Sleeve Gastroplasty Using Endomina to Treat Obesity in Adults Awaiting Kidney Transplant

What this Trial Is About

Researchers are evaluating the use of endoscopic sleeve gastroplasty ESG to help obese adults with end-stage renal disease who need a kidney transplant reduce their body mass index BMI below 35. This pilot prospective interventional study aims to find out if ESG can effectively lower BMI within 12 months and its impact on weight loss, quality of life, and obesity-related health problems. The study focuses on patients who are currently unable to be listed for transplantation due to high BMI. Participants will undergo ESG performed under general anesthesia using the Endomina4 suturing system, which creates full-thickness sutures in the stomach to reduce its volume by forming a gastric tubule. The procedure involves placing 4-8 stitches to reduce the stomach size while leaving certain stomach areas free. Participants will be followed for 12 months before transplantation and for 12 months after to monitor outcomes. During the study, participants will be assessed for their eligibility to join the kidney transplant waiting list based on BMI reduction. Researchers will monitor weight changes, quality of life, and obesity-related conditions. The study includes regular medical evaluations to check the procedures effects and any complications. Total participation spans up to 24 months, covering the pre- and post-transplant periods.

Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates