Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT03396835
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2018-01-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Desaturation Validation of INVSENSOR00009
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Desaturation Validation of INVSENSOR00009
Status:
COMPLETED
Status Verified Date:
2019-08
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 is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
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?:
None
Is an FDA AA801 Violation?: