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NCT Number: NCT07340957

Valid-B.Well BP25 Study

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: Day 1

    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.

Secondary outcomes

  1. Agreement by Bland-Altman analysis

    Time frame: Day 1

    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

  2. Population characteristics- Age

    Time frame: Day 1

    Age (descriptive summary)

  3. Population Characteristics - Sex

    Time frame: day 1

    Sex (descriptive summaries)

  4. Population Characteristics- arm circumferences

    Time frame: Day 1

    arm circumferences (descriptive summaries)

  5. Population Characteristics- baseline blood pressure categories

    Time frame: Day 1

    Normotensive/hypertensive ranges for both systolic and diastolic pressures

  6. Observser agreement

    Time frame: Day 1

    percentage of paired measurements (within +/- 4 mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Fassler Fassler

CONTACT

[email protected]

+41 79 309 93 79

Sponsors and collaborators

Lead sponsor

B.Well Swiss AG

Industry

Collaborators

  • European Cardiovascular Research Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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