Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02975050
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
Sponsor:
Zoll Medical Corporation
Organization:
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:
False
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?: