Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT03124758
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2017-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-06
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:
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
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?: