Liver TransplantNCT04194437
OCS Liver DCD Trial
A study testing OCS Liver System in people with Liver Transplant, run by TransMedics at 4 sites in United States.
Trial summary
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- OCS Liver System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jul 2020to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Registered primary liver transplant candidate
- Age ≥ 18 years
- Obtained informed consent
Who cannot join
- Acute, fulminant liver failure
- Prior solid organ or bone marrow transplant
- Ventilator dependent on day of transplant/donor organ offer
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Henry Ford Hospital
Detroit, Michigan, 48202
Mount Sinai Hospital
New York, New York, 10029
University of Texas San Antonio
San Antonio, Texas, 78249
About this study
Official title: Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
Read the detailed description
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
- Conditions
- Liver Transplant
- Being tested
- OCS Liver System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Liver SystemDevice
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.
| Study group | Role | What they receive |
|---|---|---|
| OCS Preserved Livers | Experimental | This is a single-arm trial of OCS preserved livers used for transplantation. Receives: Device: OCS Liver System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Graft Survival Through 6 Months Post-transplant
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start24 Jul 2020
- Primary completion22 Mar 2022
- Study completion16 Dec 2024
Why it stopped: Enrollment in Liver DCD was stopped as a result of the FDA approval for the OCS Liver System and follow-up ended on 12/16/2024 based on adequate patient follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Elbetanony, MD, Study director, TransMedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194437
- Sponsor's protocol ID
- OCS-LVR-092019
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2019
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
PubMed 33650998
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
- ClinicalTrials.gov ID
- NCT04194437
- Acronym / sponsor ID
- OCS-LVR-092019
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment in Liver DCD was stopped as a result of the FDA approval for the OCS Liver System and follow-up ended on 12/16/2024 based on adequate patient follow-up.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
Detailed description
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCS Preserved Livers | Experimental | Device: OCS Liver SystemThis is a single-arm trial of OCS preserved livers used for transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Registered primary liver transplant candidate
- Age ≥ 18 years
- Obtained informed consent
Key exclusion criteria (3 listed)
- Acute, fulminant liver failure
- Prior solid organ or bone marrow transplant
- Ventilator dependent on day of transplant/donor organ offer
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 |
|---|---|---|
| OCS Liver SystemThe OCS Liver System will be used to preserve, optimize and assess livers from DCD donors. | Device | OCS Preserved Livers |
Primary outcome
Liver Graft Survival Through 6 Months Post-transplant
Time frame: 6 months
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33650998Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
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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.
Ahmed Elbetanony, MD study director
TransMedics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Liver System in people with Liver Transplant, run by TransMedics at 4 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Liver Graft Survival Through 6 Months Post-transplant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194437, which also lists 1 linked publication.
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 5 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.