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OCS Liver PROTECT Continued Access Protocol
NCT04186221 · View on ClinicalTrials.gov ↗
Study Summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Conditions Studied
Interventions
- DEVICE OCS Liver System
Study Locations (17)
California
- Scripps — La Jolla
- University of California San Diego — La Jolla
- UCSF — San Francisco
Texas
- University of Texas Southwest — Dallas
- Houston Methodist Hospital — Houston
- The University of Texas Health Science Center at San Antonio — San Antonio
New York
- Mount Sinai Hospital — New York
- Montefiore Einstein Center for Transplantation — The Bronx
Virginia
- University of Virginia — Charlottesville
- Virginia Commonwealth University Health System — Richmond
Florida
- Tampa General — Tampa
Maryland
- Johns Hopkins — Baltimore
Massachusetts
- Massachusetts General Hospital — Boston
Michigan
- Henry Ford Hospital — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2023-02-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04186221
The ClinicalTrials.gov registry entry for NCT04186221 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TransMedics, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Liver Transplant appearing as the primary indexed condition, and to 1 intervention — of which OCS Liver System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04186221 reports 17 study locations spanning 11 distinct geographic areas — top geographies include California, Texas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04186221 about?
NCT04186221 is a clinical study titled "OCS Liver PROTECT Continued Access Protocol". Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
What is the current status of trial NCT04186221?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2020-02-03. Estimated completion is 2023-02-02.
What conditions does trial NCT04186221 study?
This clinical trial studies the following conditions: Liver Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04186221?
The interventions under investigation include: OCS Liver System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04186221?
This trial is sponsored by TransMedics, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04186221 being conducted?
This trial has 17 study locations across California, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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