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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital, Chicago, Illinois, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

≥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.

Treatment and study plan

Hypothermic machine perfusion

Device

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

Primary outcomes

Early Allograft Dysfunction (EAD)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Organ Recovery Systems, Inc.

Industry

Registry information

Official study title

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)

Acronym: PILOT™_CA

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Oct 10, 2022
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting