Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-22 @ 4:20 PM
Study NCT ID:
NCT05909605
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019722', 'term': 'Sphygmomanometers'}, {'id': 'D062666', 'term': 'Vascular Access Devices'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D057785', 'term': 'Catheters'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-11', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device comparison to standard monitoring (Sphygmomanometer)', 'timeFrame': '2 years', 'description': 'Clinical feasibility of the calibration accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 10 participants.'}, {'measure': 'Device comparison to standard monitoring (A-line)', 'timeFrame': '2 years', 'description': 'Clinical feasibility of the ultrasound blood pressure sensor for monitoring trend changes for continuous 12 hours of measurement in comparison to an arterial line in the Intensive Care Unit on 10 participants.'}, {'measure': 'Device comparison to standard monitoring (A-line)', 'timeFrame': '3 years', 'description': 'Clinical feasibility of the ultrasound blood pressure sensor in comparison to an arterial line in the catheterization laboratory on 40 participants.'}, {'measure': 'Device comparison to standard monitoring (Sphygmomanometer)', 'timeFrame': '4 years', 'description': 'Clinical feasibility of the device accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 90 participants in consulting room on orthostatic hypotension participants.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feasibility Study', 'Medical Device']}, 'descriptionModule': {'briefSummary': 'Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor offers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants without any severe cardiac anomalies', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are able to provide informed consent\n* Have at least one arm\n\nExclusion Criteria:\n\n* Active cardiac arrhythmias\n* Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)\n* Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)\n* Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff\n* Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure\n* Diagnosis of dementia"}, 'identificationModule': {'nctId': 'NCT05909605', 'briefTitle': 'Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch', 'orgStudyIdInfo': {'id': '804119, 191474, 191527, 210799'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound blood pressure sensor', 'interventionNames': ['Device: sphygmomanometer', 'Device: Arterial Line']}], 'interventions': [{'name': 'sphygmomanometer', 'type': 'DEVICE', 'description': 'Comparison to the ultrasound sensor', 'armGroupLabels': ['Ultrasound blood pressure sensor']}, {'name': 'Arterial Line', 'type': 'DEVICE', 'description': 'Comparison to the ultrasound sensor', 'armGroupLabels': ['Ultrasound blood pressure sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sheng Xu', 'investigatorAffiliation': 'University of California, San Diego'}}}}