Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-10 @ 11:18 AM
Study NCT ID:
NCT06519032
Status:
RECRUITING
Last Update Posted:
2024-07-26
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sputum and other specimen used for microbiologic testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of concordance between AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria', 'timeFrame': 'Day1', 'description': 'Evaluate the difference between actual medical record reports(such as culture results) and AI-estimated results regarding the presence or absence of acid-fast bacteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Specimens for microbiological testing, such as acid-fast bacilli(AFB) smear test , ordered at the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in whom acid-fast bacilli(AFB) smear test was ordered\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06519032', 'briefTitle': 'Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI', 'organization': {'class': 'INDUSTRY', 'fullName': 'GramEye'}, 'officialTitle': 'Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI', 'orgStudyIdInfo': {'id': 'GE004'}}, 'contactsLocationsModule': {'locations': [{'zip': '5650871', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Go Yamamoto', 'role': 'CONTACT'}], 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Tatsuya Yamada, M.D.', 'role': 'CONTACT', 'email': 'tatsuya.yamada@grameye.com', 'phone': '7028060149'}], 'overallOfficials': [{'name': 'Satoshi Kutsuna, PhD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Osaka University Medical Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GramEye', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Osaka University', 'class': 'OTHER'}, {'name': 'Keio University', 'class': 'OTHER'}, {'name': 'Fukujuji Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}