Trials / Completed
CompletedNCT02975050
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Zoll Medical Corporation · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Location |
Timeline
- Start date
- 2016-11-28
- Primary completion
- 2017-01-19
- Completion
- 2017-01-19
- First posted
- 2016-11-29
- Last updated
- 2020-07-07
Source: ClinicalTrials.gov record NCT02975050. Inclusion in this directory is not an endorsement.