Valid-B.Well BP25 Study

NCT07340957 | Not Yet Recruiting

• 1 other identifier: BWE-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Study Focus: Blood Pressure Measures; Volunteers

Keywords

blood pressure; iso 81060-2; upper arm blood pressure monitor; commercialized device validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Agreement by Bland-Altman analysis

  Day 1

• Population characteristics- Age

  Day 1

• Population Characteristics - Sex

  day 1

• Population Characteristics- arm circumferences

  Day 1

• Population Characteristics- baseline blood pressure categories

  Day 1

Study Arms (1)

Sigle arm

EXPERIMENTAL

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

Interventions

Blood pressure measurement DIAGNOSTIC_TEST

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.

Sigle arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 12 years
• Signed Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• B.Well Swiss AG: lead
• European Cardiovascular Research Center: collaborator

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Central Study Contacts

Thomas Fassler Fassler

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, with 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 study aims to clinically evaluate the accuracy of the B-Well PRO-25 upper arm automated sphygmomanometer for systolic blood pressure (SBP) and diastolic blood pressure (DBP) in adults and adolescents in accordance with ISO 81060-2. The comparative measurements are obtained through auscultation by an observer using a mercury sphygmomanometer (reference method).

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01