Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594198
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery Interventional Comparative Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery Interventional Comparative Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARGOS Platform
Brief Summary:
The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values comparative study with platform INVOS Medtronic
Detailed Description:
SctO2 values from ARGOS and INVOS will be resampled every 30 seconds The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test Bias and agreement limits will be assessed using Bland amp Altmann graphs This test will be carried out for the entire duration of the recording
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?:
None