Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT04835857
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2021-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-05', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Diastolic Blood Pressure', 'timeFrame': 'up to 30 minutes', 'description': '3 sets readings compared across blood pressure (mmHg)'}, {'measure': 'Comparison of Systolic Blood Pressure', 'timeFrame': 'up to 30 minutes', 'description': '3 sets readings compared across blood pressure (mmHg)'}], 'secondaryOutcomes': [{'measure': 'Skin Irritation', 'timeFrame': 'Up to 72 hours', 'description': 'Examining for local skin irritation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood Pressure, Cuff less, Wearable, BP'], 'conditions': ['Hypertension', 'Healthy']}, 'descriptionModule': {'briefSummary': '(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.', 'detailedDescription': '(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.\n* Agree to commit to participate in the current protocol.\n* Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.\n* A difference of \\>10 mm Hg in left versus right arm oscillometric systolic BP.\n* Upper extremity arteriovenous hemodialysis shunt.\n* Wrist distortion or pain from arthritis.\n* Prior trauma or surgery at the radial artery monitoring site.'}, 'identificationModule': {'nctId': 'NCT04835857', 'briefTitle': 'Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynocardia, Inc'}, 'officialTitle': 'Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure', 'orgStudyIdInfo': {'id': 'TBPI001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental-Arm', 'description': 'For the same subject,\n\n1. ViTrack wrist cuff is applied on one of the wrist\n2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm\n3. Auscultatory cuff is applied to the brachial artery of the same arm', 'interventionNames': ['Device: ViTrack', 'Device: Oscillometric BP Device', 'Device: Auscultatory cuff']}], 'interventions': [{'name': 'ViTrack', 'type': 'DEVICE', 'description': 'ViTrack is a continuous non-invasive wearable blood pressure cuff.', 'armGroupLabels': ['Experimental-Arm']}, {'name': 'Oscillometric BP Device', 'type': 'DEVICE', 'description': 'Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.', 'armGroupLabels': ['Experimental-Arm']}, {'name': 'Auscultatory cuff', 'type': 'DEVICE', 'description': 'The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.', 'armGroupLabels': ['Experimental-Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02459', 'city': 'Newton', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gokul Rajamanickam', 'role': 'CONTACT', 'email': 'gokulpr@dynocardia.care'}], 'facility': 'Dynocardia Inc', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}], 'centralContacts': [{'name': 'Mohan Thanikachalam, MD', 'role': 'CONTACT', 'email': 'admin@dynocardia.care', 'phone': '+1 (617) 639 - 5569'}, {'name': 'Gokul Prasath Rajamanickam, MS', 'role': 'CONTACT', 'email': 'gokulpr@dynocardia.care'}], 'overallOfficials': [{'name': 'Mohan Thanikachalam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dynocardia, Inc'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will become available following data analysis within 6 month of study completion and will remain available for up to 3 years.', 'ipdSharing': 'YES', 'description': "Personal and medical information will stay confidential and secure and will be protected in accordance with current US law. All participants will be provided with a unique ID number. All participants' information such as participants' name and address as well as background information will be de-identified to protect subject confidentiality.\n\nDynocardia or its designees will comply with all relevant data collection laws when collecting data for this study. Study databases will not include the participants name or address. Images will be captured by ViTrack under patient's ID in an electronic database. All other data will be de-identified for review purpose and transferred via a secure method.", 'accessCriteria': 'Data will be accessed via secure methods outlined in a data sharing agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynocardia, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}