[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639817":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":10,"locations":37,"responsibleParty":60,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Nanopath, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Vaginal Infections (BV, CV, TV)",null,[12,13,14,15,16],"Diagnostic Test: Nanopath Vaginitis Assay","Diagnostic Test: BD Max™ Vaginal Panel","Diagnostic Test: Cepheid Xpert® Xpress MVP","Diagnostic Test: Hologic Aptima® BV Assay","Diagnostic Test: Yeast Culture",[18,23,27,30,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DIAGNOSTIC_TEST","Nanopath Vaginitis Assay","Investigational Device",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"BD Max™ Vaginal Panel","This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.",[9],{"type":19,"name":28,"description":25,"armGroupLabels":29,"otherNames":10},"Cepheid Xpert® Xpress MVP",[9],{"type":19,"name":31,"description":25,"armGroupLabels":32,"otherNames":10},"Hologic Aptima® BV Assay",[9],{"type":19,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Yeast Culture","Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption\u002FIonization Time-of-Flight mass spectrometry) for required speciation.",[9],[38],{"facility":39,"status":10,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"LSU-CrescentCare Sexual Health Center","New Orleans","Louisiana","70119","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-90.07507,29.95465,{"lat":49,"lon":48},[52,57],{"name":53,"role":54,"phone":55,"phoneExt":10,"email":56},"Catherine Cammarata","CONTACT","504-568-4132","ccamma@lsuhsc.edu",{"name":58,"role":59,"phone":10,"phoneExt":10,"email":10},"Rebecca Lillis","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100639817","large-algorithm-setting-and-validation-study-100639817",false,"NCT07607470","Large Algorithm Setting and Validation Study","A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing","LAVA","Inclusion Criteria:\n\nBiologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:\n\n* Abnormal vaginal discharge\n* Vaginal or vulvar itching, burning, or irritation\n* Painful or uncomfortable intercourse\n* Vaginal odor\n* Painful or frequent urination\n\nExclusion Criteria:\n\n* Participants who do not meet the above-described inclusion criteria will be excluded from the study.\n* Previously enrolled in this study\n* Contraindication to vaginal swab sampling","FEMALE","18 Years",{"count":73,"type":74},1000,"ESTIMATED","OBSERVATIONAL","In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.\n\nThe Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.",[78,79,80,81,82,83,84,85,86,87,88,89,90],"Bacterial Infections","Bacterial Infections and Mycoses","Infections","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Urogenital Disease","Candidiasis","Mycoses","Vulvovaginitis","Vulvar Diseases","Vaginosis, Bacterial","NOT_YET_RECRUITING","2026-05-20",{"date":94,"type":95},"2026-05-26","ACTUAL",{"date":92,"type":74},{"date":98,"type":74},"2027-01",{"name":5,"class":6},1]