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New treatment option for Obesity, Morbid
Official title Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
ClinicalTrials.gov ID: NCT05917795
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
- Signed informed consent.
You likely can't join if
- 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;
See the full eligibility 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...
- Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
- Signed informed consent.
- 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. -
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.