Healthy Clinical Trial
Official title:
A Novel Non-interfering Arterial Blood Pressure Monitoring Device
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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