Status:
COMPLETED
Evaluation of the Aurora Xi New Nomogram Software 2.0
Lead Sponsor:
Fenwal, Inc.
Conditions:
Apheresis Related Hypotension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- All subjects must meet current safety guidelines for plasma donation as set forth by the FDA as well as those in the standard operating procedures established by the participating institution.
- Enrolled subjects who do not meet inclusion criteria at a later donation attempt are eligible to remain in the clinical trial and to subsequently donate plasma once they meet eligibility criteria again.
Exclusion
- Subjects not able or unwilling to give consent to participate.
- Subjects withdrawn by a qualified healthcare provider due to safety concerns.
- Subjects who are employed by the clinical site or Sponsor.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
6735 Patients enrolled
Trial Details
Trial ID
NCT06122935
Start Date
November 27 2023
End Date
May 31 2024
Last Update
November 12 2025
Active Locations (3)
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1
BioLife Plasma Services
Lakeland, Florida, United States, 33813
2
BioLife Plasma Services
West Des Moines, Iowa, United States, 50266
3
BioLife Plasma Services
American Fork, Utah, United States, 84003