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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2027-02-28

Brief Summary

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

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Detailed Description

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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

Conditions

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Liver Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypothermic Machine Perfusion

Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system

Group Type EXPERIMENTAL

Hypothermic Machine Perfusion

Intervention Type DEVICE

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

Interventions

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Hypothermic Machine Perfusion

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No