Prospective, Single-Arm, Study to Assess the Safety and P... | NCT03600285

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2018Actual

Primary Completion Date

Feb 15, 2019Actual

Completion Date

Mar 31, 2020Estimated

First Submitted Date

Jul 6, 2018

First Submission Date that Met QC Criteria

Jul 24, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2019

Last Update Posted Date

Jun 21, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
TB1-K	Experimental	TB1-K preservation arm	Device: TB1-K

Name	Type	Description	Arm Group Labels	Other Names
TB1-K	Device	Use of TB1-K for preservation and transport of donated kidneys	TB1-K

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:
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)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Unviersitario de Bellvitge		Barcelona	Hospitalet de Llobregat	08907	Spain
Hospital Universitario Vall d'Hebron