Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-30 @ 4:53 AM
Study NCT ID:
NCT03273166
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2017-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Status:
COMPLETED
Status Verified Date:
2020-10
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:
This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner.
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?:
True
Is an FDA AA801 Violation?: