Ex Vivo Normothermic Perfusion in Kidney Transplantation.
NCT05175885 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-11-12
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.
Conditions
- Kidney Transplantation
Interventions
- 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
Sponsors & Collaborators
-
Ebers Medical Technology, S.L.
lead INDUSTRY
Principal Investigators
-
Alex Gutierrez-Dalmau, MD · Miguel Servet University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-14
- Primary Completion
- 2025-12-31
- Completion
- 2027-12-31
Countries
- Spain
Study Locations
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