Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 9:11 AM
Study NCT ID:
NCT06457568
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of CONTEC08C Electronic Sphygmomanometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2024-06-08', 'studyFirstSubmitQcDate': '2024-06-08', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure measurement data', 'timeFrame': '30mintues', 'description': 'Systolic Blood Pressure and Diastolic Blood Pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 12 to 79 years\n* Subjects voluntarily participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n* Subjects with cardiac arrhythmias;\n* Pregnancy;\n* Poor quality Korotkoff sounds;\n* Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;\n* Other conditions that the investigator considers ineligible for clinical trial.'}, 'identificationModule': {'nctId': 'NCT06457568', 'briefTitle': 'Validation Study of CONTEC08C Electronic Sphygmomanometer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)', 'orgStudyIdInfo': {'id': '2023-ZX082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CONTEC08C and mercury sphygmomanometer', 'description': 'Blood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer', 'interventionNames': ['Diagnostic Test: Blood pressure measurement']}], 'interventions': [{'name': 'Blood pressure measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'The blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometer and by a supervisor using the tested device, CONTEC08C.', 'armGroupLabels': ['CONTEC08C and mercury sphygmomanometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese Academy of Medical Sciences，Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ying Lou, MD', 'role': 'CONTACT', 'email': 'fuwailou1798@sina.com', 'phone': '86(10)88392170'}], 'overallOfficials': [{'name': 'Ying Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lou ying', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}