Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05692505
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard performance criteria', 'timeFrame': '<1 day', 'description': 'Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['HIV Infections', 'Hepatitis C', 'Hepatitis B', 'Syphilis Infection']}, 'descriptionModule': {'briefSummary': 'To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device', 'detailedDescription': "Measurement Methodology Whole blood samples are collected by fingerstick. Samples tested immediately.\n\nUsing the supplied sample dropper, transfer specimen blood drop into the two sample wells. Wait 20-30 seconds. Add two drops of the supplied assay buffer (\\~90µL) to the same sample wells Read result in 20 mins.\n\nPrimary end points will determine how accurate these tests are (p\\<=0.02) by analyzing for:\n\nDiagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.\n\nAn estimated 200 patients are to be enrolled as follows:\n\n150 with a documented medical history of HIV, HBV, HCV or Syphilis. A combination of 2 or 3 conditions is acceptable.\n\nHbsAg patients need to have a HbsAg on file \\< 2 years. HIV and HCV or Syphilis patients only need one antibody test in their medical chart.\n\n50 with no documented medical history of HIV, HBV, HCV or Syphilis and are considered normal.\n\nMale or female subjects, ages ≥18 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study patients are seen, recruited and consented from local clinics and physician offices.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\na documented medical history of HIV, HBV, HCV or syphilis. A combination of 2 or 3 conditions is acceptable.\n\nHbsAg patients need to have a HbsAg on file \\< 2 years. HIV and HCV patients only need one antibody test in their medical chart. no documented medical history of HIV, HBV, HCV or syphilis and are considered normal.\n\nMale or female subjects, ages ≥18 years. Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).-\n\nExclusion Criteria:\n\nAny other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.\n\nParticipation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-'}, 'identificationModule': {'nctId': 'NCT05692505', 'briefTitle': 'Multicenter Performance Study of QuadQuik Invitro Diagnostic Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genlantis Diagnostics'}, 'officialTitle': 'Multicenter Performance Study of QuadQuik Invitro Diagnostic Device', 'orgStudyIdInfo': {'id': 'genl-qq-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive test subjects', 'description': 'Subjects having previous positive tests verified by certified laboratory', 'interventionNames': ['Diagnostic Test: QuadQuik']}, {'label': 'Control subjects', 'description': 'Subjects having no previous positive tests verified by certified laboratory', 'interventionNames': ['Diagnostic Test: QuadQuik']}], 'interventions': [{'name': 'QuadQuik', 'type': 'DIAGNOSTIC_TEST', 'description': 'Invitro diagnostic device', 'armGroupLabels': ['Control subjects', 'Positive test subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Robert H. Zeiler, PhD', 'role': 'CONTACT'}, {'name': 'Ahsan Awan, JD', 'role': 'CONTACT'}], 'facility': 'Genlantis Diagnostics', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Robert H Zeiler, PhD', 'role': 'CONTACT', 'email': 'rezeiler1970@gmail.com', 'phone': '7074779081'}, {'name': 'Ahsan Awan, JD', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genlantis Diagnostics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ahsan Awan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}