Status:
TERMINATED
WP02 Continued Access Study
Lead Sponsor:
OrganOx Ltd.
Collaborating Sponsors:
North American Science Associates Ltd.
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
- Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04862156
Start Date
October 10 2021
End Date
July 7 2023
Last Update
April 15 2025
Active Locations (7)
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1
University of Colorado
Aurora, Colorado, United States, 80045
2
Loyola University Chicago
Maywood, Illinois, United States, 60153
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Washington University
St Louis, Missouri, United States, 63110