[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619156":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":29,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":40,"sex":41,"minAge":42,"maxAge":20,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":20},{"fullName":5,"class":6},"B.Well Swiss AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Diagnostic Test: Blood pressure measurement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Thomas Fassler Fassler","CONTACT","+41 79 309 93 79","thomas.faessler@bwell-swiss.ch",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[30],{"name":31,"class":32},"European Cardiovascular Research Center","NETWORK","100619156","valid-bwell-bp25-study-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":44,"type":45},100,"ESTIMATED","INTERVENTIONAL",[48],"NA","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.",[51,52],"Volunteers","Study Focus: Blood Pressure Measures",[54,55,56,57],"blood pressure","iso 81060-2","upper arm blood pressure monitor","commercialized device validation","NOT_YET_RECRUITING","2026-01-05",{"date":61,"type":62},"2026-01-14","ACTUAL",{"date":64,"type":45},"2026-01",{"date":66,"type":45},"2026-03",{"name":5,"class":6}]