Apheresis Related Hypotension Clinical Trial
Official title:
Evaluation of the Aurora Xi New Nomogram Software 2.0
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
A controlled, prospective, randomized, multicenter, IDE clinical trial to evaluate the safety and effectiveness of a new plasma collection volume nomogram on the Aurora Xi Plasmapheresis System (test arm) as compared to the currently marketed Optimized Nomogram on the Aurora Xi Plasmapheresis System (control arm). The new plasma collection volume nomogram will provide a more individualized approach to determining the volume of plasma collected from each donor. The trial will be conducted at a minimum of 3 plasma collection centers. Subjects will be randomized into the test and control arms. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04320823 -
IMPACT (Improving Plasma Collection) Clinical Trial
|
N/A |