Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05175885
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2021-12-02
Brief Title:
Ex Vivo Normothermic Perfusion in Kidney Transplantation
Sponsor:
Ebers Medical Technology SL
Organization:
Ebers Medical Technology SL
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KidneyARK
Brief 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 System 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 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 System in kidney transplantation from DCD and DBD donors
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 System in kidney transplantation from DCD and DBD donors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None