Valid-B.Well BP25 Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorB.Well Swiss AG

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

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

B.Well Swiss AG

Lead sponsor

European Cardiovascular Research Center

Collaborator