Valid-B.Well BP25 Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Volunteers; Study Focus: Blood Pressure Measures
• Intervention / Treatment: Diagnostic test: Blood pressure measurement

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Fassler Fassler; Phone Number: +41 79 309 93 79; Email: thomas.faessler@bwell-swiss.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;
• Subjects with vascular accesses in the arms or arteriovenous shunt tubes;
• Subjects who have participated in other clinical trials within the past 1 month;
• Subjects for whom the procedures during the clinical trial may pose excessive medical risks;
• Subjects determined by the investigator to be unsuitable for participating in the clinical study.
• Subject under judicial protection, guardianship or curatorship or participant deprived of their liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sigle arm; Single-arm. All subjects will undergo blood pressure measurement with the reference manual method and with upper arm automated sphygmomanometer (3 times each).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The study will assess compliance with the following validation criteria defined by the standard ISO 81060-2:2018: Criterion 1 - Group-level accuracy (paired-difference analysis). Criterion 2 - Subject-level accuracy	The study will assess compliance with the following validation criteria defined by the standard ISO 81060-2:2018 for SBP and DBP (in mmHg): Criterion 1 - Group-level accuracy (paired-difference analysis). For systolic blood pressure (SBP) and diastolic blood pressure (DBP) separately, the mean difference between the test device and the reference method (observer auscultation with a mercury sphygmomanometer) across all valid paired determinations shall be within ±5 mmHg, and the standard deviation (SD) of these differences shall be ≤ 8 mmHg. Criterion 2 - Subject-level accuracy For SBP and DBP, each subject's mean difference (test device - reference) shall be calculated from that subject's repeated paired determinations. The standard deviation of these subject-level means across all subjects shall comply with the requirements specified in Table 1 Averaged subject data acceptance in mmHg of ISO 81060-2:2018 (1) for SBP and DBP.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement by Bland-Altman analysis	Calculation of the bias (average difference between test device and reference method) and the 95% limits of agreement (LoA) for systolic blood pressure (SBP) and diastolic blood pressure (DBP), overall and across the blood pressure range	Day 1
Population characteristics- Age	Age (descriptive summary)	Day 1
Population Characteristics - Sex	Sex (descriptive summaries)	day 1
Population Characteristics- arm circumferences	arm circumferences (descriptive summaries)	Day 1
Population Characteristics- baseline blood pressure categories	Normotensive/hypertensive ranges for both systolic and diastolic pressures	Day 1
Observser agreement	percentage of paired measurements (within +/- 4 mmHg)	Day 1

Collaborators and Investigators

• Sponsor: B.Well Swiss AG
• Collaborators: European Cardiovascular Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure; iso 81060-2; upper arm blood pressure monitor; commercialized device validation
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Physical Examination; Blood Pressure Determination
• Other Study ID Numbers: BWE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No