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

November 2, 2023 updated by: Organ Recovery Systems, Inc.

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
          • Daniel Borja-Cacho, MD
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago Medical Center
        • Contact:
          • John Fung, MD
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • Recruiting
        • Rutgers New Jersey Medical School
        • Contact:
          • James V. Guarrera, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Not yet recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Shimul Shah, MD

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • ≥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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypothermic Machine Perfusion
Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system
Device: Hypothermic Machine Perfusion
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organ Recovery Systems, Inc.

Investigators

  • Study Director: Stan Harris, Organ Recovery Systems
  • Study Chair: Matthew Copithorne, 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 Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-US-02-ORS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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