NCT05917795 Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
| NCT ID | NCT05917795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Obesity, Morbid |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-09-24 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-09-24 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. -
Frequently Asked Questions
Who can join the NCT05917795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05917795 currently recruiting?
Yes, NCT05917795 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione Policlinico Universitario Agostino Gemelli IRCCS to inquire about joining.
Where is the NCT05917795 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05917795 clinical trial?
NCT05917795 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 24 participants.
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