ACTIVE_NOT_RECRUITING

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

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Conditions

Liver Transplantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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)

Quick Facts

Study Start:2022-09-19
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05574361

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Subject is a multi-organ transplant recipient.
  2. * Subject is antibodies blood group (ABO) liver incompatible.
  3. * Subject has severe systemic infection.
  4. * Subject is Human Immunodeficiency Virus (HIV) positive.
  5. * Subject has acute/fulminant liver failure.
  6. * Subject is pregnant.

Contacts and Locations

Principal Investigator

Carrie Lindower
STUDY_DIRECTOR
Organ Recovery Systems
Matthew Copithorne
STUDY_CHAIR
Organ Recovery Systems

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Intermountain Medical Center
Murray, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Organ Recovery Systems, Inc.

  • Carrie Lindower, STUDY_DIRECTOR, Organ Recovery Systems
  • Matthew Copithorne, STUDY_CHAIR, Organ Recovery Systems

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-19
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-09-19
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Transplantation