Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-18 @ 8:21 AM
Study NCT ID:
NCT02418923
Status:
None
Last Update Posted:
2016-05-11 00:00:00
First Post:
2015-04-13 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HemoSonics-UVA Spinal Surgery
Sponsor:
None
Organization:
Study Overview
Official Title:
HemoSonics-UVA Spinal Surgery Clinical Study Protocol
Status:
None
Status Verified Date:
2016-05
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:
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.
Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology
Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: