Vital Signs Validation Study of the μ-Cor System (ViVUS Validation) (ViVUS)

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.

Study Overview

• Status: Completed
• Conditions: Health Volunteer Validation Study
• Intervention / Treatment: Other: Location

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.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

• Subject is at least 21 years of age or older.
• Subject is willing and able to sign the Informed Consent Form.
• Subject is healthy, able and willing to complete all the preparation steps and study procedures.

Exclusion Criteria

• Female subject with a known pregnancy or unsure about pregnancy status.
• Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
• Subjects with skin breakdown in areas where device placement is required.
• Subjects with chronic lung disease or asthma.
• Subjects with a history of cardiovascular diseases.
• Subjects who are diabetic.
• Subjects living with kidney failure or dialysis.
• Subjects with a history of liver failure.
• Subjects with any known malignancy (i.e. cancer patients).
• Subjects with implanted devices in the thoracic region

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Side location; u-Cor device will be applied on side location	Other: Location
Front location; u-Cor device will be applied on front location	Other: Location

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).	Immediately
Posture	90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position	Immediately
Activity	μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.	Immediately
Heart Rate		Immediately
ECG		Immediately

Collaborators and Investigators

• Sponsor: Kyma Medical Technologies

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): January 19, 2017
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-KM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO