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

NCT ID: NCT03600285

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2020-03-31

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.

Conditions

Kidney Preservation and Transportation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TB1-K

TB1-K preservation arm

Group Type: EXPERIMENTAL

TB1-K

Intervention Type: DEVICE

Use of TB1-K for preservation and transport of donated kidneys

Interventions

TB1-K

Use of TB1-K for preservation and transport of donated kidneys

Intervention Type: DEVICE

Eligibility Criteria

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

1. Registered primary kidney transplant candidate, male or female

2. Age ≥ 18 years old

3. Signed written informed consent

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Transplant Biomedicals, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fritz Diekmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic i provincial de Barcelona

Locations

Hospital Unviersitario de Bellvitge

Barcelona, Hospitalet de Llobregat, Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

TB/TB1K-001

Identifier Type: -

Identifier Source: org_study_id