[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"study-focus-blood-pressure-measures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:study-focus-blood-pressure-measures":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Volunteers","Study Focus: Blood Pressure Measures",[30,31,32,33],"blood pressure","iso 81060-2","upper arm blood pressure monitor","commercialized device validation","NOT_YET_RECRUITING","2026-01-05",{"date":37,"type":38},"2026-01-14","ACTUAL",{"date":40,"type":21},"2026-01",{"date":42,"type":21},"2026-03",{"name":44,"class":45},"B.Well Swiss AG","INDUSTRY"]