Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-06-17 @ 5:45 PM
Study NCT ID:
NCT03610269
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2018-07-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Status:
COMPLETED
Status Verified Date:
2019-06
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:
The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: