Liver TransplantationPILOT™_CANCT05574361
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
A study testing Hypothermic Machine Perfusion in people with Liver Transplantation, run by Organ Recovery Systems, Inc. at 5 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Hypothermic Machine Perfusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Sep 2022to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Intermountain Medical Center
Murray, Utah, 84107
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
About this study
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)
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
Read the 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
- Conditions
- Liver Transplantation
- Being tested
- Hypothermic Machine Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic Machine PerfusionDevice
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
| Study group | Role | What they receive |
|---|---|---|
| Hypothermic Machine Perfusion | Experimental | Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system Receives: Device: Hypothermic Machine Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start19 Sep 2022
- Primary completion23 Sep 2025
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organ Recovery Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carrie Lindower, Study director, Organ Recovery SystemsMatthew Copithorne, Study chair, Organ Recovery Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574361
- Sponsor's protocol ID
- 2020-US-02-ORS
- Acronym
- PILOT™_CA
- Status last verified
- May 2026
- First submitted
- 6 Oct 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05574361
- Acronym / sponsor ID
- PILOT™_CA / 2020-US-02-ORS
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Organ Recovery Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothermic Machine Perfusion | Experimental | Device: Hypothermic Machine PerfusionHypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermic Machine PerfusionOrgan Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution | Device | Hypothermic Machine Perfusion |
Primary outcome
Early Allograft Dysfunction (EAD)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Lindower study director
Organ Recovery Systems
Matthew Copithorne study chair
Organ Recovery Systems
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermic Machine Perfusion in people with Liver Transplantation, run by Organ Recovery Systems, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Allograft Dysfunction (EAD) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.