NCT07340957

Valid-B.Well BP25 Study

Validation of the B. Well Digital Upper Arm Blood Pressure Monitor Pro-25 According to ISO 81060- 2

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: B.Well Swiss AG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Volunteers
• Study Focus: Blood Pressure Measures

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood pressure measurement	All measurements will be performed by trained observers in line with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard (1), ensuring accuracy, consistency, and reproducibility. The investigation shall be performed in an isolated room under comfortable ambient temperature. * The cuff shall be applied on the bare arm with no compression proximal to the cuff. * The subject shall rest quietly for at least 10 minutes prior to the start of measurements. * The subject should avoid talking during the entire measurement procedure. * BP shall be measured on the subject's left arm at heart level. * A minimum of 5 minutes shall elapse prior to obtaining the first reference blood pressure measurement.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-01-14
• Last updated: 2026-01-14