Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
- Conditions
- Health Volunteer Validation Study
- Interventions
- Other: Location
- Registration Number
- NCT02975050
- Lead Sponsor
- Kyma Medical Technologies
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Side location Location u-Cor device will be applied on side location Front location Location u-Cor device will be applied on front location
- Primary Outcome Measures
Name Time Method Heart Rate Immediately Posture Immediately 90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position
Respiratory rate Immediately The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).
Activity Immediately μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.
ECG Immediately
- Secondary Outcome Measures
Name Time Method