Liver TransplantationNCT05526326
OrganOx Metra® New Enrollment PAS
An observational study of Liver Transplantation, run by OrganOx Ltd. at 10 sites in United States.
Trial summary
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting. 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?
- Transplant with normothermic machine perfused (NMP) donor liver
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 10 sitesUnited States
- Study dates
- 10 Nov 2022to 5 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating study centers
Who may be able to join
- Subject is 18 years of age or greater
- Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Subject is able and willing to comply with all study requirements (in the opinion of the Investigator)
Who cannot join
- Subject requiring all of the following at the time of transplantation:
- Oxygen therapy via a ventilator/respirator
- Inotropic support
- Renal replacement therapy
- Subject has acute/fulminant liver failure (UNOS status 1A)
- Subject planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor
- Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
The Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
University of Wisconsin
Madison, Wisconsin, 53792
Loyola University
Maywood, Illinois, 60153
Mount Sinai
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: OrganOx Metra® New Enrollment Post-Approval Study
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.
Read the detailed description
The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.
- Conditions
- Liver Transplantation
- Being tested
- Transplant with normothermic machine perfused (NMP) donor liver
- Keywords
- Liver transplantation, Normothermic perfusion, Biliary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant with normothermic machine perfused (NMP) donor liverDevice
Also called OrganOx metra® normothermic machine perfusion
The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®
| Study group | Role | What they receive |
|---|---|---|
| Post-Approval Transplant Recipient cohort | Adult liver transplant recipients who are transplanted with an OrganOx metra® perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria Receives: Device: Transplant with normothermic machine perfused (NMP) donor liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse biliary-related events
Adverse biliary-related events as measured by biliary complications
Measured: 12-months post-transplant
Secondary outcomes (2)
Graft survival
Liver graft survival post-liver transplant as measured by the number of subjects needing a re-transplant
Measured: 12-months post-transplant
Subject survival
Subject survival post-liver transplant
Measured: 12-months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start10 Nov 2022
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrganOx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526326
- Sponsor's protocol ID
- P200035/PAS003
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OrganOx Metra® New Enrollment Post-Approval Study
- ClinicalTrials.gov ID
- NCT05526326
- Acronym / sponsor ID
- P200035/PAS003
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, Normothermic perfusion, Biliary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- OrganOx Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 2 Sep 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.
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.
Detailed description
The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Approval Transplant Recipient cohort | – | Device: Transplant with normothermic machine perfused (NMP) donor liverAdult liver transplant recipients who are transplanted with an OrganOx metra® perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating study centers
Key inclusion criteria (4 listed)
- Subject is 18 years of age or greater
- Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Subject is able and willing to comply with all study requirements (in the opinion of the Investigator)
Key exclusion criteria (8 listed)
- Subject requiring all of the following at the time of transplantation:
- Subject has acute/fulminant liver failure (UNOS status 1A)
- Subject planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor
- Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.
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 |
|---|---|---|
| Transplant with normothermic machine perfused (NMP) donor liverAlso: OrganOx metra® normothermic machine perfusionThe enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra® | Device | Post-Approval Transplant Recipient cohort |
Primary outcome
Adverse biliary-related events
Time frame: 12-months post-transplant
Adverse biliary-related events as measured by biliary complications
2 secondary outcomes
Graft survival
Time frame: 12-months post-transplant
Subject survival
Time frame: 12-months post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by OrganOx Ltd. at 10 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse biliary-related events (time frame: 12-months post-transplant). 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 Apr 2025.