WP02 Continued Access Study
Stopped early · Not applicable
Conditions studied: Liver Transplantation
In brief
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.
Key facts
- Study ID
- NCT04862156
- Run by
- OrganOx Ltd.
- People needed
- 19
- Starts
- 2021-10-10
- Expected to finish
- 2023-07-07
- Last updated by the study team
- 2025-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Colorado — Aurora, Colorado, United States
- Loyola University Chicago — Maywood, Illinois, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Washington University — St Louis, Missouri, United States
- Duke University — Durham, North Carolina, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Wisconsin-Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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