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

Description

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

Conditions

Liver Transplantation

Study Overview

Study Details

Study overview

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

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)

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

Condition
Liver Transplantation
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Newark

Rutgers New Jersey Medical School, Newark, New Jersey, United States, 07101

Cincinnati

University of Cincinnati Medical Center, Cincinnati, Ohio, United States, 45267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Organ Recovery Systems, Inc.,

Stan Harris, STUDY_DIRECTOR, Organ Recovery Systems

Matthew Copithorne, STUDY_CHAIR, Organ Recovery Systems

Study Record Dates

2025-12-31