NCT01805180

Evaluation of the Spectra Optia PMN Cell Collection Procedure

A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Terumo BCT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.

Detailed description

The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.

Conditions

• Granulocyte/ Polymorphonuclear Cells

Interventions

Type	Name	Description
DEVICE	Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)	In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.
DEVICE	Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)	In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-03-06
• Last updated: 2015-03-18
• Results posted: 2014-11-26

Locations

3 sites across 1 country: United States