Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT05981495
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2023-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D000092225', 'term': 'Tuberculosis, Extrapulmonary'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NanoDetect-TB result compared to sputum culture', 'timeFrame': 'Single visit for patient for blood draw.', 'description': 'The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity.'}], 'secondaryOutcomes': [{'measure': 'NanoDetect-TB result compared to AFB Smear and NAAT', 'timeFrame': 'Single visit for patient for blood draw.', 'description': 'The investigational device results will be further compared to the AFB Smear and NAAT for determining relative sensitivity and specificity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tuberculosis, Pulmonary', 'Tuberculosis, Extrapulmonary', 'Tuberculosis Active']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to have TB disease.\n\nThe main question\\[s\\] it aims to answer are:\n\n* How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?\n* How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays?\n\nParticipants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children and adults aged two years or older (including older adults that are 65+)\n* Ability and willingness to provide informed consent/assent/permission, and a parent/legal guardian willing to give consent on the child's behalf for study participants aged 2-17 years\n* Ability and willingness to perform study procedures, or parent/legal guardian to provide consent for a child to undergo study procedures on their behalf (when applicable)\n* Clinical signs and symptoms typically associated with active TB disease including, but not limited to:\n\nCough for \\> two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever Chest pain Night sweats\n\n* Physician (or healthcare provider) suspicion of TB disease\n\nExclusion Criteria:\n\n* Pregnancy (based on participant-provided information)\n* Any physical or mental health condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject and/or prevent, limit, or confound protocol-specified procedures\n* Critical illness needing immediate medical care\n* Receipt of treatment for active TB or LTBI in the past 24 months"}, 'identificationModule': {'nctId': 'NCT05981495', 'briefTitle': 'Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'NanoPin Technologies, Inc.'}, 'officialTitle': 'Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease', 'orgStudyIdInfo': {'id': 'NanoDetect-TB_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TB Suspects', 'description': 'TB Suspects recruited to this study will have blood drawn in a single visit.', 'interventionNames': ['Device: NanoDetect-TB']}], 'interventions': [{'name': 'NanoDetect-TB', 'type': 'DEVICE', 'description': 'This study of the NanoDetect-TB investigational device will test plasma and serum samples from TB suspects. There is no intervention for the subjects and there will be a single visit blood draw.', 'armGroupLabels': ['TB Suspects']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Thomas Tombler, Ph.D.', 'role': 'CONTACT', 'email': 'ttombler@nanopintech.com', 'phone': '18056800377'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NanoPin Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fortrea', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}