RecruitingNot ApplicableNCT07792317

Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation

A Single-center, Non-randomized, Uncontrolled Pilot Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation


Sponsor

Vivalyx GmbH

Enrollment

15 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function. Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Omnisol organ preservation solution for people with end stage renal disease (esrd), kidney failure, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOmnisol organ preservation solution

Omnisol for HMP of deceased donor kidneys


Locations(1)

Erasmus Medical Center

Rotterdam, Netherlands

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NCT07792317


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