Liver TransplantNCT05096754
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
An observational study of Liver Transplant, run by TransMedics at 11 sites in United States.
Trial summary
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP. 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
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 11 sitesUnited States
- Study dates
- 3 Feb 2020to 2 Feb 2023
- 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: Subjects transplanted in the OCS Liver PROTECT CAP
Who may be able to join
- Subjects transplanted in the OCS Liver PROTECT CAP
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas Southwest
Dallas, Texas, 75390
Houston Methodist Hospital
Houston, Texas, 77030
Scripps
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92037
Mount Sinai
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
About this study
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.
- Conditions
- Liver Transplant
- Being tested
- OCS Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS LiverDevice
Transplant with an OCS preserved liver.
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Survival
Liver Graft Survival at 24 months post-transplant.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start3 Feb 2020
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096754
- Sponsor's protocol ID
- OCS-LVR-02-PAS
- Status last verified
- May 2023
- First submitted
- 15 Oct 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
- ClinicalTrials.gov ID
- NCT05096754
- Acronym / sponsor ID
- OCS-LVR-02-PAS
- Conditions
- Liver Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 27 Oct 2021 (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.
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects transplanted in the OCS Liver PROTECT CAP
Key inclusion criteria (1 listed)
- Subjects transplanted in the OCS Liver PROTECT CAP
Key exclusion criteria (0 listed)
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 LiverTransplant with an OCS preserved liver. | Device | – |
Primary outcome
Graft Survival
Time frame: 24 Months
Liver Graft Survival at 24 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 8 Dec 2023.
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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.
11 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 Transplant, run by TransMedics at 11 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 1 inclusion and 0 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Graft Survival (time frame: 24 Months). 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 8 Dec 2023.