Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
Study NCT ID:
NCT01333761
Status:
TERMINATED
Last Update Posted:
2013-01-09
First Post:
2011-03-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiox Shunt Detection Technology Study
Sponsor:
Cardiox Corporation
Organization:
Study Overview
Official Title:
FDS-0004 Cardiox Shunt Detection Technology Study
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: