Trials / Completed
CompletedNCT06122935
Evaluation of the Aurora Xi New Nomogram Software 2.0
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6,735 (actual)
- Sponsor
- Fenwal, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aurora Xi New Nomogram Software 2.0 | Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor. |
| DEVICE | Aurora Xi Currently Approved Software 1.3 | Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System |
Timeline
- Start date
- 2023-11-27
- Primary completion
- 2024-04-19
- Completion
- 2024-05-31
- First posted
- 2023-11-08
- Last updated
- 2025-11-12
- Results posted
- 2025-11-12
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06122935. Inclusion in this directory is not an endorsement.