Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 11:56 AM
Study NCT ID:
NCT03997461
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2019-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2019-06-23', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices', 'timeFrame': '24 hours', 'description': 'Mean of the absolute differences in systolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours'}, {'measure': 'Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices', 'timeFrame': '24 hours', 'description': 'Mean of the absolute differences in diastolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Pressure'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions', 'detailedDescription': 'The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions. Measurements will be taken at 15 minutes intervals during the day and 30 minutes intervals during the night.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Difference in blood pressure between the arms higher than 10 mmHg'}, 'identificationModule': {'nctId': 'NCT03997461', 'briefTitle': 'Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Comparison of Arterial Tonometry Sensor (BPro) With Standard Oscillometric Blood Pressure Monitoring Device (Oscar 2) for Ambulatory Use', 'orgStudyIdInfo': {'id': '170706006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BPro vs Oscar 2', 'description': 'Blood pressure measurement with BPro and Oscar 2 simultaneously during 24 hours under ambulatory conditions', 'interventionNames': ['Device: BPro']}], 'interventions': [{'name': 'BPro', 'type': 'DEVICE', 'description': 'BPro and Oscar 2 comparison for 24 hours', 'armGroupLabels': ['BPro vs Oscar 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7820436', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Institute for Biological and Medical Engineering', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Maria Rodriguez Fernandez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontificia Universidad Catolica de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comisión Nacional de Investigación Científica y Tecnológica', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}