Clinical trial NCT03600285: Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
Official title: Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Preservation and Transportation
Keywords: VIVIAN
Lead sponsor: Transplant Biomedicals, S.L.
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Donor Inclusion Criteria:

1. Donor kidney suitable for preservation
2. Only one kidney per donor will be included
3. Cold ischemia time (CIT) ≤ 24 hours
4. Donor age over 18 years old
5. Donor meets one of the following:

   1. Donor after brain death (DBD), standard and extended criteria
   2. Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
6. Signed written informed consent

Donor Exclusion Criteria:

1. 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
2. Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14)
3. Living donors
4. Previous usage of a perfusion machine (PM)
5. Kidneys not considered suitable for preservations
6. Positive serology (HIV, Hepatitis B surface antigen \& C)

Recipient Inclusion Criteria:

1. Registered primary kidney transplant candidate, male or female
2. Age ≥ 18 years old
3. Signed written informed consent

Recipient Exclusion Criteria:

1. Prior solid organ or bone marrow transplant
2. Multi-organ transplant
3. Active malignancy
4. Active infection
5. Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method.
6. Participation in another clinical trial.
7. Patient with known donor-specific HLA antibody

Primary outcomes:
measure: Rate of DGF
timeFrame: 1 week after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Unviersitario de Bellvitge
state: Hospitalet De Llobregat
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
affiliation: Hospital Clinic i provincial de Barcelona
name: Fritz Diekmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: