Actively Recruiting
Prospective Pilot Study to Evaluate Endoscopic Sleeve Gastroplasty With Endomina4 for Obesity Treatment in Kidney Transplant Candidates
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-28
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 procedure's effects and any complications. Total participation spans up to 24 months, covering the pre- and post-transplant periods.
CONDITIONS
Brief 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...
- Adult patients aged between 18 and 70 years
- Body mass index (BMI) of 35 kg/m2 or higher
- Chronic kidney disease stages G4-G5 with glomerular filtration rate below 30 ml/min/1.73 m2
- Expected to reach end-stage kidney disease 6 to 12 months before dialysis or already on stable hemodialysis
- Not listed for kidney transplant due to high BMI per transplant center policy
- Signed informed consent
You will not qualify if you...
- Patients on peritoneal dialysis
- Upper gastrointestinal bleeding in the past six months
- Active cancer within the last 5 years
- Recent myocardial infarction or severe heart failure (class III or IV)
- Previous surgery on the stomach, esophagus, or duodenum
- Technical issues preventing the procedure as judged by the endoscopist
- Signs of active infection
- Unstoppable anticoagulant or antiplatelet therapy except low dose aspirin (100 mg or less)
- Active drug or alcohol abuse
- Pregnancy or lactation, or desire to become pregnant during the study
- Participation in other clinical studies
- Contraindication to general anesthesia
- Other conditions excluding participation per investigator opinion
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure recovery
Participants undergo endoscopic sleeve gastroplasty (ESG) to reduce stomach volume under general anesthesia.
1 procedure visit and follow-up visits as needed
Duration - Up to 12 months
Participants are monitored for up to 12 months to assess kidney transplant list inclusion and health status.
Periodic follow-up visits over 12 months
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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