Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT07219693
Status:
RECRUITING
Last Update Posted:
2025-10-23
First Post:
2025-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
QuantaFlo HD Clinical Validation Study
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': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-10-20', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': 'From enrollment to the end of treatment is up to 1 week', 'description': 'Evaluate the sensitivity and specificity of QuantaFlo HD test results to GLS findings.'}], 'secondaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'From enrollment to the end of treatment is up to 1 week', 'description': 'Accuracy comparing QuantaFlo HD test results to GLS findings'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cardiovascular function', 'transthoracic echocardiography', 'global longitudinal strain'], 'conditions': ['To Assess Cardiovascular Function']}, 'descriptionModule': {'briefSummary': 'The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration ("FE"). The study examines whether Echo-measured GLS values greater than -16% correlate with abnormal responses during FE as measured by QuantaFlo HD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted at three clinical sites: one primary care clinic and one cardiac clinic, both with established echo referral pathways, and one dedicated echo clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adult (≥ age 22) subjects with a minimum of 1 of the following:\n* A history of Cardiovascular Diseasei or PAD\n* Recorded history of at least two of the following\n* Hypertension\n* Diabetes\n* Hyperlipidemia\n\nExclusion Criteria:\n\n* Unable to safely perform a forced expiration, or unable to obtain a technically adequate FE test result\n* Subjects with a pacemaker or ICD with pacemaker function\n* Terminal advanced illness\n* Recent cardiothoracic surgery (within 12 months)\n* Retinal eye disease with anticoagulants\n* History of eye surgery, within 90 days\n* Uncontrolled hypertension \\>180 mmHg systolic pressure or \\>100 mmHg diastolic pressure\n* Subjects with severe tremors'}, 'identificationModule': {'nctId': 'NCT07219693', 'briefTitle': 'QuantaFlo HD Clinical Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Semler Scientific'}, 'officialTitle': 'QuantaFlo HD Clinical Validation Study', 'orgStudyIdInfo': {'id': '35-0262-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'QuantaFlo HD', 'type': 'DEVICE', 'description': 'blood flow at the finger during a forced expiration'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Varela', 'role': 'CONTACT', 'email': 'Monica.Varela@usheartandvascular.com', 'phone': '520-975-6400'}, {'name': 'Thomas Waggoner', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paul Bejarano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pima Heart and Vascular', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'centralContacts': [{'name': 'Gena Parker', 'role': 'CONTACT', 'email': 'gparker@semlerscientific.com', 'phone': '669-230-2729'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semler Scientific', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}