Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:25 AM
Study NCT ID:
NCT07340957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valid-B.Well BP25 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001795', 'term': 'Blood Pressure Determination'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D010808', 'term': 'Physical Examination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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)).\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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Day 1', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Agreement by Bland-Altman analysis', 'timeFrame': 'Day 1', 'description': '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': 'Population characteristics- Age', 'timeFrame': 'Day 1', 'description': 'Age (descriptive summary)'}, {'measure': 'Population Characteristics - Sex', 'timeFrame': 'day 1', 'description': 'Sex (descriptive summaries)'}, {'measure': 'Population Characteristics- arm circumferences', 'timeFrame': 'Day 1', 'description': 'arm circumferences (descriptive summaries)'}, {'measure': 'Population Characteristics- baseline blood pressure categories', 'timeFrame': 'Day 1', 'description': 'Normotensive/hypertensive ranges for both systolic and diastolic pressures'}, {'measure': 'Observser agreement', 'timeFrame': 'Day 1', 'description': 'percentage of paired measurements (within +/- 4 mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure', 'iso 81060-2', 'upper arm blood pressure monitor', 'commercialized device validation'], 'conditions': ['Volunteers', 'Study Focus: Blood Pressure Measures']}, 'descriptionModule': {'briefSummary': "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)).\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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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 \\<22 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'}, 'identificationModule': {'nctId': 'NCT07340957', 'briefTitle': 'Valid-B.Well BP25 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'B.Well Swiss AG'}, 'officialTitle': 'Validation of the B. Well Digital Upper Arm Blood Pressure Monitor Pro-25 According to ISO 81060- 2', 'orgStudyIdInfo': {'id': 'BWE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sigle arm', 'description': 'Single-arm. All subjects will undergo blood pressure measurement with the reference manual method and with upper arm automated sphygmomanometer (3 times each).', 'interventionNames': ['Diagnostic Test: Blood pressure measurement']}], 'interventions': [{'name': 'Blood pressure measurement', 'type': 'DIAGNOSTIC_TEST', 'description': "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.\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.", 'armGroupLabels': ['Sigle arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Thomas Fassler Fassler', 'role': 'CONTACT', 'email': 'thomas.faessler@bwell-swiss.ch', 'phone': '+41 79 309 93 79'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B.Well Swiss AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'European Cardiovascular Research Center', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}