About this trial
Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, repeated measures accuracy study designed in accordance with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard for the clinical validation of automated non-invasive sphygmomanometers (Non-invasive sphygmomano-meters - Part 2: Clinical investigation of intermittent automated measurement, including Amendments 1 and 2)).
The validation will be conducted with volunteers rather than necessarily with patients, and all measurements will be performed outside of the subjects' normal diagnosis or treatment.
Eligibility criteria
Qualifiers
Age > 12 years
Signed Informed Consent
Disqualifiers
Any medical condition preventing light to moderate arm compression
Absence of the upper arm
Subjects with upper arm circumference <22 cm or >42 cm
Subjects with severe shock;
Trial design
Treatments tested in this trial
- Blood pressure measurement
Treatment groups
Locations
Sponsors and collaborators
B.Well Swiss AG
Lead sponsor
European Cardiovascular Research Center
Collaborator