Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-09 @ 2:41 AM
Study NCT ID:
NCT06491433
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2024-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of H2-BP Electronic Sphygmomanometer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019722', 'term': 'Sphygmomanometers'}, {'id': 'D001795', 'term': 'Blood Pressure Determination'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D010808', 'term': 'Physical Examination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CARDIOBK@yuhs.ac', 'phone': '+82-10-2721-8813', 'title': 'Byoung Kwon Lee', 'organization': 'Department of Cardiology at Gangnam Severance hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1day', 'description': 'Death, serious adverse events, and other(non-serious adverse events) were not assessed for the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Test Subjects Using H2-BP and Big Ben® Sphygmomanometer', 'description': 'Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).\n\nH2-BP: The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.\n\n1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.\n2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.\n\nDue to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Subjects Using H2-BP and Big Ben® Sphygmomanometer', 'description': 'Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).\n\nH2-BP: The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.\n\n1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.\n2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.\n\nDue to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.'}], 'classes': [{'title': 'systolic blood pressure', 'categories': [{'measurements': [{'value': '0,276', 'spread': '0,937', 'groupId': 'OG000'}]}]}, {'title': 'diastolic blood pressure', 'categories': [{'measurements': [{'value': '-0,004', 'spread': '0,904', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'serial assessment during 1 day', 'description': 'Average difference between blood pressure measurements obtained with the test medical device and the comparator.\n\nStandard deviation of the difference between blood pressure measurements obtained with the test medical device and the comparator (based on the number of measurements).', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Subjects Using H2-BP and Big Ben® Sphygmomanometer', 'description': 'Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).\n\nH2-BP: The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.\n\n1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.\n2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.\n\nDue to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.'}], 'classes': [{'title': 'systolic blood pressure', 'categories': [{'measurements': [{'value': '0,276', 'spread': '0,789', 'groupId': 'OG000'}]}]}, {'title': 'diastolic blood pressure', 'categories': [{'measurements': [{'value': '-0,004', 'spread': '0,735', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'secondary outcome will be out in 1 day', 'description': 'Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants)', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Subjects Using H2-BP and Big Ben® Sphygmomanometer', 'description': 'Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).\n\nH2-BP: The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.\n\n1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.\n2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.\n\nDue to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'consent withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Subjects Using H2-BP and Big Ben® Sphygmomanometer', 'description': 'Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).\n\nH2-BP: The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.\n\n1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.\n2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.\n\nDue to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.69', 'spread': '12.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-07', 'size': 690334, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-10T23:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2024-06-30', 'resultsFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2024-06-30', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-10', 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.', 'timeFrame': 'serial assessment during 1 day', 'description': 'Average difference between blood pressure measurements obtained with the test medical device and the comparator.\n\nStandard deviation of the difference between blood pressure measurements obtained with the test medical device and the comparator (based on the number of measurements).'}], 'secondaryOutcomes': [{'measure': 'Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.', 'timeFrame': 'secondary outcome will be out in 1 day', 'description': 'Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Blood Pressure', 'Normal Blood Pressure', 'Prehypertension', 'Hypertension']}, 'descriptionModule': {'briefSummary': "The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Each subject undergoes alternating measurements of H2-BP on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. The two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. Measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. Validity assessment variables are derived from the recorded values to evaluate the accuracy of H2-BP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'Gender Eligibility Description: At least 30% of the total participants must be composed of each gender (male and female)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients and inpatients aged 19 years or older showing hypotension, normal blood pressure, prehypertension, and hypertension\n* Individuals who meet the criteria for wrist circumference, age, gender, and upper arm circumference as specified in the target number of participants.\n* Those who have listened to a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with precautions.\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the study.\n* Individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions.\n* Those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications.\n* Individuals with arrhythmia.\n* Those who have eaten within 30 minutes before blood pressure measurement.\n* Individuals who have consumed caffeine-containing beverages within 1 hour or smoked within 15 minutes before measurement.\n* Participants who have exercised immediately before blood pressure measurement.\n* Other patients deemed unsuitable for the study at the discretion of the researchers.'}, 'identificationModule': {'nctId': 'NCT06491433', 'briefTitle': 'Clinical Trial of H2-BP Electronic Sphygmomanometer', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'A Prospective, Single Arm, Single Center, Non-randomized, Open Label Study to Evaluate the Accuracy of the Wrist Blood Pressure Monitor (H2-BP) Comparing With Aneroid Sphygmomanometer', 'orgStudyIdInfo': {'id': '3-2022-0427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test subjects using H2-BP and big ben® Sphygmomanometer', 'description': 'Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).', 'interventionNames': ['Device: H2-BP']}], 'interventions': [{'name': 'H2-BP', 'type': 'DEVICE', 'otherNames': ['Sphygmomanometer', 'Blood Pressure Measurement'], 'description': 'The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.\n\n1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.\n2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.\n\nDue to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.', 'armGroupLabels': ['Test subjects using H2-BP and big ben® Sphygmomanometer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital,', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Byoung Kwon Lee', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}