Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-30 @ 12:23 AM
Study NCT ID:
NCT04894669
Status:
TERMINATED
Last Update Posted:
2025-04-10
First Post:
2021-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Convenience Sample Data Collection for INVSENSOR00045
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Convenience Sample Data Collection for INVSENSOR00045
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: