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

Kyma Medical Technologies

Status

Completed

Conditions

Health Volunteer Validation Study

Treatments

Other: Location

Study type

Observational

Funder types

Industry

Identifiers

NCT02975050

2016-KM-001

Details and patient eligibility

About

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:

Side location (below left armpit) for study arm 1, and
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.

Full 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:

Side location (below left armpit) for study arm 1, and
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.

Enrollment

30 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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