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Recruiting NCT05917795

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

No phase Interventional Obesity, Morbid End Stage Renal Disease Kidney Transplantation Endoscopic Sleeve Gastroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Sleeve Gastroplasty (ESG).
Who it may be relevant to
Registry conditions: Obesity, Morbid, End Stage Renal Disease, Kidney Transplantation, Endoscopic Sleeve Gastroplasty. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 (GIF-H190/GIF-HQ190; Olympus Medical Systems Corp., Tokyo, Japan) 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 free. The ESG starts with the reduction of the gastric body, suturing from di

Primary outcome measures

  • Kidney transplant list inclusion [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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);
  • Signed informed consent.

Exclusion criteria

  • 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;
  • Previous stomach, oesophagus or duodenum surgery;
  • Technical non-feasibility in the opinion of the endoscopist;
  • Clinical signs of active infection;
  • Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
  • Active drugs or alcohol abuse;
  • Pregnancy, lactation (desire to become pregnant during study duration);
  • Enrolment in other clinical studies;
  • Contraindication to general anaesthesia;
  • Other conditions to exclude the subject in investigators opinion;
  • Refusal to sign informed consent. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Identifiers

NCT: NCT05917795 · 5764

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗