NCT05175885

Ex Vivo Normothermic Perfusion in Kidney Transplantation.

Multicenter, Prospective and Open-label Clinical Trial to Evaluate the Viability, Performance and Safety of ex Vivo Normothermic Perfusion in Kidney Transplantation From DCD and DBD Donors.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ebers Medical Technology, S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.

Detailed description

The Ark Kidney is a medical device for ex vivo normothermic perfusion intended to create the conditions that allow kidneys to be resuscitated and / or preserved prior to transplantation. It consists of a permanent unit, which is retained after each perfusion, and a disposable circuit called the ARK Kidney Kidney Disposable Set (KDS), which must be replaced after perfusion to ensure sterile conditions. It is a portable organ perfusion system designed to preserve a kidney by continuous perfusion of the donated organ with warm oxygenated perfusate supplemented with erythrocytes from the blood bank. The perfusion solution circulates continuously through the vascular network of the organ in a closed circuit. During perfusion, the system can monitor organ perfusion parameters, as well as the conditions of the perfusion solutions and the volume of urine generated during the perfusion. The primary objective of the clinical study is to assess the viability, performance and safety of ex vivo normothermic perfusion with the Ark Kidney in kidney transplantation from DCD and DBD donors.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DEVICE	Ex vivo normothermic perfusion	Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System
DEVICE	Cold preservation	Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft

Timeline

• Start date: 2023-12-14
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2022-01-04
• Last updated: 2024-11-12

Locations

1 site across 1 country: Spain