NCT05574361

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2022Feb 2027

Study Start

First participant enrolled

September 19, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Expected
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

October 6, 2022

Last Update Submit

January 21, 2026

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hypothermic Machine Perfusion

EXPERIMENTAL

Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system

Device: Hypothermic Machine Perfusion

Interventions

Hypothermic Machine PerfusionDEVICE

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

Hypothermic Machine Perfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Study Officials

  • Carrie Lindower

    Organ Recovery Systems

    STUDY DIRECTOR

  • Matthew Copithorne

    Organ Recovery Systems

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

September 19, 2022

Primary Completion

February 1, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)