Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 9:29 AM
Study NCT ID:
NCT04539860
Status:
UNKNOWN
Last Update Posted:
2020-09-07
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Results', 'timeFrame': 'Single visit; up to one day', 'description': 'Comparison of Transdermal Optical Imaging data and Standard assessment data'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. The data collected will help improve the blood pressure measurement accuracy of Transdermal Optical Imaging, which relies on machine learning to extract physiological information from videos recorded.', 'detailedDescription': 'There are many ways to measure blood pressure (monitors, mercury sphygmomanometer, aneroid devices), with most relying on a cuff-inflation. Transdermal Optical Imaging measures blood pressure using a video captured by any conventional camera (e.g., those on a phone, tablet, laptop) and advanced machine learning algorithms.\n\nThe current study aims to improve the accuracy of Transdermal Optical Imaging algorithms for measuring blood pressure. The investigators will recruit participants (patients with medical problems and healthy volunteers) to have their blood pressure measured in various ways (e.g.,by registered nurses with sphygmomanometer and stethoscope, continuous blood pressure monitor, etc.). Further, participants will have their faces video-recorded intermittently between standard measurements or at the same time as standard measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Only individuals, of any sex, over the age of 13 will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04539860', 'briefTitle': 'Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care', 'orgStudyIdInfo': {'id': '32755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls', 'description': 'Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging', 'interventionNames': ['Device: Transdermal Optical Imaging']}, {'label': 'Patients', 'description': 'Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging', 'interventionNames': ['Device: Transdermal Optical Imaging']}], 'interventions': [{'name': 'Transdermal Optical Imaging', 'type': 'DEVICE', 'description': 'Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging', 'armGroupLabels': ['Healthy Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 1A1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Si Jia Wu, MA', 'role': 'CONTACT', 'email': 'sijia.wu@mail.utoronto.ca'}], 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Gu, PhD', 'role': 'CONTACT', 'email': 'xiaopinggu@nju.edu.cn'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deye Yang, MD', 'role': 'CONTACT', 'email': 'deyeyang@126.com'}], 'facility': 'The Affiliated Hospital of Hangzhou Normal University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Kang Lee, PhD', 'role': 'CONTACT', 'email': 'kang.lee@utoronto.ca', 'phone': '416-934-4597'}, {'name': 'Si Jia Wu, MA', 'role': 'CONTACT', 'email': 'sijia.wu@mail.utoronto.ca'}], 'overallOfficials': [{'name': 'Kang Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared with other researchers outside the team of researchers involved in the current study. Findings of the study based on group results will be shared in publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nuralogix Corporation', 'class': 'INDUSTRY'}, {'name': 'The Affiliated Hospital of Hangzhou Normal University', 'class': 'OTHER'}, {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kang Lee', 'investigatorAffiliation': 'University of Toronto'}}}}