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

• Sponsor: Organ Recovery Systems, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05574361
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 15.4
• Patients Per Site: 60
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation	Device: Hypothermic Machine Perfusion	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Sep 19, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Early Allograft Dysfunction (EAD) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• ≥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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
2	Rutgers New Jersey Medical School	Newark	New Jersey	United States	07101

Sponsors and Collaborators

• Organ Recovery Systems, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organ Recovery Systems, Inc.
• ClinicalTrials.gov Identifier: NCT05574361
• Other Study ID Numbers: 2020-US-02-ORS
• First Posted: Oct 10, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Oct 12, 2022