Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation

Study Overview
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Brief Summary
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TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient. This is a prospective, single-arm, multi-center study comparing to a historical control for cold storage. The study is conducted in accordance with the Standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice), and other legal requirements. The study objective is to assess the safety and performance of the TB1-K device in donor kidneys intended for transplantation.

Official Title
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Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation

Conditions
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Kidney Preservation and Transportation

Intervention / Treatment
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* Device: TB1-K


Participation Criteria
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Eligibility Criteria
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Donor Inclusion Criteria: Donor kidney suitable for preservation Only one kidney per donor will be included Cold ischemia time (CIT) ≤ 24 hours Donor age over 18 years old Donor meets one of the following: Donor after brain death (DBD), standard and extended criteria Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled) Signed written informed consent Donor Exclusion Criteria: Kidney, which investigator is unwilling to use, or presence of moderate or severe traumatic kidney injury, or anatomical kidney vascular abnormalities, which would preclude the organ from being acceptable by the transplant surgeon Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14) Living donors Previous usage of a perfusion machine (PM) Kidneys not considered suitable for preservations Positive serology (HIV, Hepatitis B surface antigen & C) Recipient Inclusion Criteria: Registered primary kidney transplant candidate, male or female Age ≥ 18 years old Signed written informed consent Recipient Exclusion Criteria: Prior solid organ or bone marrow transplant Multi-organ transplant Active malignancy Active infection Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method. Participation in another clinical trial. Patient with known donor-specific HLA antibody

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TB1-K<br>TB1-K preservation arm | Device: TB1-K<br>* Use of TB1-K for preservation and transport of donated kidneys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of DGF | Rate of delayed graft function (DGF), defined as need for dialysis in the first week after transplant, once hyperacute rejection, vascular and urinary tract complications are ruled out. | 1 week after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VIVIAN