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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. 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 criteria

Qualifiers

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

BMI ≥ 35 kg/m²;

Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate [GFR] <30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible;

Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);

Disqualifiers

Patients on peritoneal dialysis

Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months;

Ongoing or active malignancy during the last 5 years

Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification;

Trial design

Treatments tested in this trial

  • Endoscopic Sleeve Gastroplasty (ESG)

Treatment groups

24 Participants
are divided into 1 treatment group