Actively Recruiting
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-28
24
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 70 years
- Body mass index (BMI) of 35 kg/m2 or higher
- Chronic kidney disease G4-G5 with glomerular filtration rate below 30 ml/min/1.73 m2
- Expected to reach end-stage kidney disease at least 6 to 12 months before dialysis or stable on haemodialysis with irreversible kidney failure
- Not listed for kidney transplant due to high BMI (cut-off 35 kg/m2)
- Signed informed consent
You will not qualify if you...
- Currently on peritoneal dialysis
- Upper gastrointestinal bleeding in the last six months
- Active cancer in the past 5 years
- Myocardial infarction in the past 6 months or heart failure class III or IV
- Previous surgery on stomach, esophagus, or duodenum
- Procedure considered not feasible by the endoscopist
- Signs of active infection
- Unstoppable anticoagulant or antiplatelet therapy except low-dose aspirin (≤100 mg)
- Active drug or alcohol abuse
- Pregnancy, lactation, or desire to become pregnant during the study
- Participation in other clinical studies
- Contraindication to general anesthesia
- Other conditions excluding participation as decided by investigators
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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