Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT05581394
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of BabySat V3 With Profound Hypoxia and Motion
Sponsor:
Owlet Baby Care, Inc.
Organization:
Study Overview
Official Title:
Accuracy of BabySat V3 With Profound Hypoxia and Motion
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: