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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).
Full 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.
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Inclusion criteria
Exclusion criteria
Breached skin
Acknowledged pregnancy
Pacemaker
Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
Implanted metal in upper limb:
Presence of an arterial-venous shunt
Recent axillary node dissection
Primary purpose
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Interventional model
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0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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