[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619156":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":41,"interventions":48,"overallOfficials":33,"centralContacts":54,"locations":33,"responsibleParty":60,"collaborators":62,"id":66,"slug":33,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":33,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":33,"enrollmentInfo":75,"targetDuration":33,"studyType":78,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":89,"whyStopped":33,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":33},{"fullName":5,"class":6},"B.Well Swiss AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"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):\n\nCriterion 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.\n\nCriterion 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",[14,17,20,24,27,30],{"measure":15,"description":16,"timeFrame":12},"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",{"measure":18,"description":19,"timeFrame":12},"Population characteristics- Age","Age (descriptive summary)",{"measure":21,"description":22,"timeFrame":23},"Population Characteristics - Sex","Sex (descriptive summaries)","day 1",{"measure":25,"description":26,"timeFrame":12},"Population Characteristics- arm circumferences","arm circumferences (descriptive summaries)",{"measure":28,"description":29,"timeFrame":12},"Population Characteristics- baseline blood pressure categories","Normotensive\u002Fhypertensive ranges for both systolic and diastolic pressures",{"measure":31,"description":32,"timeFrame":12},"Observser agreement","percentage of paired measurements (within +\u002F- 4 mmHg)",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NA","SINGLE_GROUP","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\u002FESH\u002FISO 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)).\n\nThe 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.\n\nThe comparative measurements are obtained through auscultation by an observer using a mercury sphygmomanometer (reference method).","OTHER",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"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).",[47],"Diagnostic Test: Blood pressure measurement",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"DIAGNOSTIC_TEST","Blood pressure measurement","All measurements will be performed by trained observers in line with the requirements of the ISO 81060-2:2018 AAMI\u002FESH\u002FISO Universal Standard (1), ensuring accuracy, consistency, and reproducibility.\n\nThe investigation shall be performed in an isolated room under comfortable ambient temperature.\n\n* The cuff shall be applied on the bare arm with no compression proximal to the cuff.\n* The subject shall rest quietly for at least 10 minutes prior to the start of measurements.\n* The subject should avoid talking during the entire measurement procedure.\n* BP shall be measured on the subject's left arm at heart level.\n* A minimum of 5 minutes shall elapse prior to obtaining the first reference blood pressure measurement.",[43],[55],{"name":56,"role":57,"phone":58,"phoneExt":33,"email":59},"Thomas Fassler Fassler","CONTACT","+41 79 309 93 79","thomas.faessler@bwell-swiss.ch",{"type":61,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[63],{"name":64,"class":65},"European Cardiovascular Research Center","NETWORK","100619156",false,"NCT07340957","Valid-B.Well BP25 Study","Validation of the B. Well Digital Upper Arm Blood Pressure Monitor Pro-25 According to ISO 81060- 2","Inclusion Criteria:\n\n* Age \\> 12 years\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Any medical condition preventing light to moderate arm compression\n* Absence of the upper arm\n* Subjects with upper arm circumference \\\u003C22 cm or \\>42 cm\n* Subjects with severe shock;\n* Subjects with a history of mental illness or current mental disorders;\n* Patients with arrhythmias (atrial premature beats, ventricular premature beats, atrial fibrillation, etc.) or upper limb arteriosclerosis (at the direct measurement site);\n* Subjects using extracorporeal circulation devices;\n* Subjects with excessive limb asymmetry;\n* Subjects who have undergone mastectomy or lymph node dissection;\n* Subjects with arm injuries or exposed wounds, or those with circulatory disorders;\n* Subjects with vascular accesses in the arms or arteriovenous shunt tubes;\n* Subjects who have participated in other clinical trials within the past 1 month;\n* Subjects for whom the procedures during the clinical trial may pose excessive medical risks;\n* Subjects determined by the investigator to be unsuitable for participating in the clinical study.\n* Subject under judicial protection, guardianship or curatorship or participant deprived of their liberty by judicial or administrative decision",true,"ALL","12 Years",{"count":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[35],"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\u002FESH\u002FISO 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)).\n\nThe 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.",[82,83],"Volunteers","Study Focus: Blood Pressure Measures",[85,86,87,88],"blood pressure","iso 81060-2","upper arm blood pressure monitor","commercialized device validation","NOT_YET_RECRUITING","2026-01-05",{"date":92,"type":93},"2026-01-14","ACTUAL",{"date":95,"type":77},"2026-01",{"date":97,"type":77},"2026-03",{"name":5,"class":6}]