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Evaluation of the Aurora Xi New Nomogram Software 2.0

NCT06122935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6735

Last updated 2025-11-12

Study results available
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Summary

A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.

Conditions

  • Apheresis Related Hypotension

Interventions

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

Sponsors & Collaborators

  • Fenwal, Inc.

    lead INDUSTRY

Principal Investigators

  • Carrie Pineda · Fresenius Kabi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2024-04-19
Completion
2024-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122935 on ClinicalTrials.gov