A Novel Non-interfering Arterial Blood Pressure Monitoring Device
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Sense A/S
- Primary Endpoint
- Accuracy of measurement
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
Brief Summary
The primary purpose of this investigation is to validate the performance and safety of the Investigational Device (ID) against a validated and legally cleared device for measuring Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a period of 24 hours against a validated and legally cleared device for Ambulatory Blood Pressure Monitoring (ABPM).
Detailed Description
The clinical investigation is conducted as a controlled (subject as own control), prospective, randomised, comparative investigation in a population with a representative spread of BPs to ensure that the ID performs as good as current marketed and approved devices. The study will be conducted in compliance with the International Standard ANSI/AAMI/ISO 81060-2 - Non-invasive sphygmomanometers - Clinical validation of automated measurement type. This clinical investigation will enrol up to 96 male and female subjects to ensure the recording of 85/35 evaluable datasets in accordance with the ANSI/AAMI/ISO standard \[11\]. All measurements will be paired and falls into 2 categories: Auscultatory measurements as gold standard reference, oscillometric measurements for clinical practise reference and further validation of ambulatory monitoring and pulse shape measurements.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 30% of the subjects must be males (n=29)
- •At least 30% of the subjects must be female (n=29)
- •Age ≥ 18 years old
- •Limb size circumference ≥ 17 cm
- •Blood pressure distribution:
- •At least 25 % of the subjects should be hypertensive
- •At least 5 % of the subjects should be hypotensive
Exclusion Criteria
- •Breached skin
- •Acknowledged pregnancy
- •Pacemaker
- •Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
- •Implanted metal in upper limb:
- •Elbow prosthesis
- •Shoulder prosthesis
- •Metal screws
- •Bone plates
- •Metal chips
Outcomes
Primary Outcomes
Accuracy of measurement
Time Frame: Up to 4 months
The reference measurements are compared with the measurements made by the investigational device
Secondary Outcomes
- Skin irritation(Up to 4 months)