VolunteersNCT07340957
Valid-B.Well BP25 Study
A study testing Blood pressure measurement in people with Volunteers and Study Focus: Blood Pressure Measures, run by B.Well Swiss AG.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers, Study Focus: Blood Pressure Measures
- What is being tested?
- Blood pressure measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age > 12 years
- Signed Informed Consent
Who cannot join
- 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);
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Volunteers, Study Focus: Blood Pressure Measures
- Being tested
- Blood pressure measurement
- Keywords
- blood pressure, iso 81060-2, upper arm blood pressure monitor, commercialized device validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
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
Measured: Day 1
Population characteristics- Age
Age (descriptive summary)
Measured: Day 1
Population Characteristics - Sex
Sex (descriptive summaries)
Measured: day 1
Population Characteristics- arm circumferences
arm circumferences (descriptive summaries)
Measured: Day 1
Population Characteristics- baseline blood pressure categories
Normotensive/hypertensive ranges for both systolic and diastolic pressures
Measured: Day 1
Observser agreement
percentage of paired measurements (within +/- 4 mmHg)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.Well Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340957
- Sponsor's protocol ID
- BWE-01
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the B. Well Digital Upper Arm Blood Pressure Monitor Pro-25 According to ISO 81060- 2
- ClinicalTrials.gov ID
- NCT07340957
- Acronym / sponsor ID
- BWE-01
- Conditions
- Volunteers, Study Focus: Blood Pressure Measures
- Keywords
- blood pressure, iso 81060-2, upper arm blood pressure monitor, commercialized device validation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- B.Well Swiss AGIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Sigle arm | Experimental | Diagnostic Test: Blood pressure measurementSingle-arm. All subjects will undergo blood pressure measurement with the reference manual method and with upper arm automated sphygmomanometer (3 times each). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 12 years
- Signed Informed Consent
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurementAll 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. | Diagnostic test | Sigle arm |
Primary outcome
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.
6 secondary outcomes
Agreement by Bland-Altman analysis
Time frame: Day 1
Population characteristics- Age
Time frame: Day 1
Population Characteristics - Sex
Time frame: day 1
Population Characteristics- arm circumferences
Time frame: Day 1
Population Characteristics- baseline blood pressure categories
Time frame: Day 1
Observser agreement
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure measurement in people with Volunteers and Study Focus: Blood Pressure Measures, run by B.Well Swiss AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Fassler Fassler (+41 79 309 93 79, thomas.faessler@bwell-swiss.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.