Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT02930850
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2016-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Status:
COMPLETED
Status Verified Date:
2019-04
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 purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
Detailed Description:
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.
Study Oversight
Has Oversight DMC:
False
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?: