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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Fassler Fassler | Contact | +41 79 309 93 79 | thomas.faessler@bwell-swiss.ch |
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| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D010808 | Physical Examination |
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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).
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|
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 |