Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484452
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
SpO2 Validation Study - Philips FAST 2024
Sponsor:
Philips Clinical Medical Affairs Global
Organization:
Philips Clinical Medical Affairs Global
Study Overview
Official Title:
SpO2 Validation Study - Philips FAST 2024
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
FAST 2024
Brief Summary:
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis
Detailed Description:
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips FAST Pulse Oximetry technology during non-motion conditions over the range of 70-100 SaO2 when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None