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Valid-B.Well BP25 Study | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Valid-B.Well BP25 Study

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

NCT07340957•B.Well Swiss AG

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age \> 12 years
•Signed Informed Consent

Exclusion Criteria

•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;
•Subjects with a history of mental illness or current mental disorders;
•Patients with arrhythmias (atrial premature beats, ventricular premature beats, atrial fibrillation, etc.) or upper limb arteriosclerosis (at the direct measurement site);
•Subjects using extracorporeal circulation devices;
•Subjects with excessive limb asymmetry;
•Subjects who have undergone mastectomy or lymph node dissection;
•Subjects with arm injuries or exposed wounds, or those with circulatory disorders;
+5 more criteria

Key Dates

Start Date

January 1, 2026

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

January 14, 2026

Enrollment

100

ESTIMATED participants

Conditions

VolunteersStudy Focus: Blood Pressure Measures

Interventions

Blood pressure measurement

DIAGNOSTIC_TEST

Contacts

Thomas Fassler Fassler

CONTACT

+41 79 309 93 79 thomas.faessler@bwell-swiss.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Valid-B.Well BP25 Study

Inclusion Criteria

Exclusion Criteria

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