Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-03 @ 7:27 AM
Study NCT ID:
NCT03650192
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2018-08-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
INVSENSOR00027 Clinical Performance Study
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
INVSENSOR00027 Clinical Performance Study
Status:
COMPLETED
Status Verified Date:
2021-01
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 assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
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?: