Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02975050
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2016-11-22
Brief Title:
Vital Signs Validation Study of the μ-Cor System ViVUS Validation
Sponsor:
Kyma Medical Technologies
Organization:
Kyma Medical Technologies
Study Overview
Official Title:
Vital Signs Validation Study of the μ-Cor System ViVUS Validation
Status:
COMPLETED
Status Verified Date:
2020-07
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:
ViVUS
Brief Summary:
This study has the following objective
To validate the capability of the μ-Cor System to monitor ECG Heart Rate HR Respiration Rate RR Posture and Activity in healthy human subjects
The μ-Cor validation will be demonstrated at two body locations
1 Side location below left armpit for study arm 1 and
2 Front location upper left chest for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device
To validate the capability of the μ-Cor System to monitor ECG Heart Rate HR Respiration Rate RR Posture and Activity in healthy human subjects
The μ-Cor validation will be demonstrated at two body locations
1 Side location below left armpit for study arm 1 and
2 Front location upper left chest for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device
Detailed Description:
This study has the following objective
To validate the capability of the μ-Cor System to monitor ECG Heart Rate HR Respiration Rate RR Posture and Activity in healthy human subjects
The μ-Cor validation will be demonstrated at two body locations
1 Side location below left armpit for study arm 1 and
2 Front location upper left chest for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device
To validate the capability of the μ-Cor System to monitor ECG Heart Rate HR Respiration Rate RR Posture and Activity in healthy human subjects
The μ-Cor validation will be demonstrated at two body locations
1 Side location below left armpit for study arm 1 and
2 Front location upper left chest for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None