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

Liver Transplantation Clinical Trial

— PILOT™_CA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574361
• Other study ID #: 2020-US-02-ORS
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Organ Recovery Systems, Inc.
• Contact: Stan Harris
• Phone: 847-824-2600
• Email: sharris[@]organ-recovery.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• =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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Rutgers New Jersey Medical School	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Organ Recovery Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Allograft Dysfunction (EAD)	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