Valid-B.Well BP25 Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorB.Well Swiss AG
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age > 12 years
Signed Informed Consent
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Blood pressure measurement
Diagnostic testAll 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Sigle armExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Day 1Secondary outcomes
1
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
Time frame
Day 12
Population characteristics- Age
Age (descriptive summary)
Time frame
Day 13
Population Characteristics - Sex
Sex (descriptive summaries)
Time frame
day 14
Population Characteristics- arm circumferences
arm circumferences (descriptive summaries)
Time frame
Day 1Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
B.Well Swiss AG
Lead sponsor
European Cardiovascular Research Center
Collaborator
Source ClinicalTrials.gov
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