Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06719518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device
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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Diastolic Blood Pressure', 'timeFrame': 'From start of surgery up to 24 hours after surgery', 'description': '255 time points compared across continuous blood pressure (mmHg)'}, {'measure': 'Comparison of Systolic Blood Pressure', 'timeFrame': 'From start of surgery up to 24 hours after surgery', 'description': '255 time points compared across continuous blood pressure (mmHg)'}], 'secondaryOutcomes': [{'measure': 'Number of participants who show signs of Skin Irritation', 'timeFrame': 'From start of surgery up to 72 hours after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ViTrack', 'blood pressure monitoring'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to calibrate the ViTrack™ arterial pressure waveform against intra-arterial pressure (IAP) in dynamic clinical settings and to assess the optimized ViTrack™ design to measure and continuously track blood pressure over a wide, clinically-relevant pressure range.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects scheduled to undergo noncardiac surgery with likely invasive arterial pressure monitoring will be included will be included', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled to undergo noncardiac surgery with general or spinal anesthesia\n* clinical indication for invasive intra-arterial pressure monitoring\n* palpable pulse\n\nExclusion Criteria:\n\n* difference of greater than 10 mmHg in the left versus right arm oscillometric systolic blood pressure\n* Upper extremity arteriovenous hemodialysis shunt\n* Upper extremity amputation\n* Planned surgical position/draping that precludes access to the wrist\n* Wrist distortion or pain from arthritis\n* Prior trauma or surgery at the radial artery monitoring site\n* Unable to provide informed consent\n* Clinical contraindication as determined by the clinical team or study investigators'}, 'identificationModule': {'nctId': 'NCT06719518', 'briefTitle': 'Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0970'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ViTrack device', 'interventionNames': ['Device: ViTrack device']}], 'interventions': [{'name': 'ViTrack device', 'type': 'DEVICE', 'description': 'In the operating room the ViTrack™ device will be applied the wrist. Monitoring will start in the operating room and will continue throughout the surgery. The device can be worn on either wrist. It will be connected to a power unit that will capture blood pressure data and stream the data to a secure laptop', 'armGroupLabels': ['ViTrack device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Mehmet Turan, MD', 'role': 'CONTACT', 'email': 'Mehmet.A.Turan@uth.tmc.edu', 'phone': '713-500-6251'}, {'name': 'Mohammad Khudirat', 'role': 'CONTACT', 'email': 'Mohammad.Khudirat@uth.tmc.edu', 'phone': '(713) 500-6200'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mehmet Turan, MD', 'role': 'CONTACT', 'email': 'Mehmet.A.Turan@uth.tmc.edu', 'phone': '(713) 500-6251'}, {'name': 'Mohammad Khudirat', 'role': 'CONTACT', 'email': 'Mohammad.Khudirat@uth.tmc.edu', 'phone': '(713) 500-5558'}], 'overallOfficials': [{'name': 'Mehmet Turan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mehmet Turan', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}