Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT04203251
Status:
UNKNOWN
Last Update Posted:
2019-12-18
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean time to acquire images', 'timeFrame': 'Up to 3 months', 'description': 'Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance'}, {'measure': 'Percentage of attempted studies with clinically useful images', 'timeFrame': 'Up to 3 Months', 'description': 'Compare the percentage of clinically useful versus not useful images'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Artificial Intelligence', 'Cardiac Monitoring'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the medical surgery step down unit at UCSF.', 'eligibilityCriteria': 'Inclusion Criteria: .\n\n* Patients ≥18 years old\n* Patients in the medical surgery step-down clinical setting\n* Patients who consent to participating in the study\n\nExclusion Criteria: .\n\n* ● Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention\n\n * Unable to lie flat for study\n * Patients experiencing a known or suspected acute cardiac event at the time of evaluation\n * Patients with severe chest wall abnormalities\n * Patients who have undergone pneumonectomy\n * Patients with recent abdominal surgery\n * Patients unwilling or unable to give written informed consent\n * Principal Investigator determination to exclude the subject from participation\n * Investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.'}, 'identificationModule': {'nctId': 'NCT04203251', 'briefTitle': 'Evaluation of TTE Utilization in Medical Surgery Step-Down Unit', 'organization': {'class': 'INDUSTRY', 'fullName': 'Caption Health, Inc.'}, 'officialTitle': 'Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology', 'orgStudyIdInfo': {'id': 'CHUCSF01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caption Health Guidance Technology', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Trevor Jensen, MD', 'role': 'CONTACT', 'email': 'trevor.jensen@ucsf.edu', 'phone': '415-476-7472'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Jade Andora, BS', 'role': 'CONTACT', 'email': 'jade@captionhealth.com', 'phone': '831-521-3821'}, {'name': 'Sara Cosenza, MA', 'role': 'CONTACT', 'email': 'saracosenza@captionhealth.com', 'phone': '301-512-8640'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caption Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}