Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-11 @ 4:15 AM
Study NCT ID:
NCT04490759
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QStat Pilot Reference Range Study
Sponsor:
HemoSonics LLC
Organization:
Study Overview
Official Title:
Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Detailed Description:
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: