Endoscopic stomach procedure for obesity in kidney transplant candidates
Tests an endoscopic stomach-shaping procedure in adults with obesity awaiting kidney transplant.
Plain-language title generated from the registry record
Registry title: Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
Key facts
- Where
- Rome, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05917795, who can take part
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT05917795
- Record updated
- 28 February 2024
- Original description
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:Read full original descriptionShow less
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
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.
Inclusion: 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: Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months; Previous stomach, oesophagus or duodenum surgery; Active drugs or alcohol abuse; 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; Clinical signs of active infection; Other conditions to exclude the subject in investigators opinion; Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg); Patients on peritoneal dialysis; Technical non-feasibility in the opinion of the endoscopist; Pregnancy, lactation (desire to become pregnant during study duration); Enrolment in other clinical studies; Contraindication to general anaesthesia; Refusal to sign informed consent. -.