Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)

A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05574361

Acronym

PILOT™_CA

Enrollment

385

Registered

2022-10-10

Start date

2022-09-19

Completion date

2026-10-23

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Brief summary

To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

Detailed description

To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial

Interventions

DEVICEHypothermic Machine Perfusion

Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥18 years of age. * Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation. * De novo liver transplant recipient. * Written informed consent required.

Exclusion criteria

* Subject is a multi-organ transplant recipient. * Subject is antibodies blood group (ABO) liver incompatible. * Subject has severe systemic infection. * Subject is Human Immunodeficiency Virus (HIV) positive. * Subject has acute/fulminant liver failure. * Subject is pregnant.

Design outcomes

Primary

Measure	Time frame	Description
Early Allograft Dysfunction (EAD)	7 days	EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) \>2000IU/L or Alanine Aminotransferase (ALT) \> 2000 IU/L

Countries

United States

Contacts

STUDY_DIRECTORCarrie Lindower

Organ Recovery Systems

STUDY_CHAIRMatthew Copithorne