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

Organ Recovery Systems

Status: Enrolling

Conditions: Liver Transplantation

Treatments: Device: Hypothermic Machine Perfusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT05574361

2020-US-02-ORS

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• ≥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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Hypothermic Machine Perfusion

Experimental group

Description:

Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system

Treatment:

Device: Hypothermic Machine Perfusion