[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639817":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":10,"locations":37,"responsibleParty":78,"collaborators":10,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":10,"enrollmentInfo":90,"targetDuration":10,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"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],[38,61],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Segal Trials","RECRUITING","North Miami","Florida","33161","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.18671,25.89009,{"lat":50,"lon":49},[53,58],{"name":54,"role":55,"phone":56,"phoneExt":10,"email":57},"Anna Kaplan","CONTACT","347-678-6542","akaplan@segaltrials.com",{"name":59,"role":60,"phone":10,"phoneExt":10,"email":10},"Steven Chavoustie, MD, FACOG, CCRP","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":40,"city":63,"state":64,"zip":65,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"LSU-CrescentCare Sexual Health Center","New Orleans","Louisiana","70119",{"type":47,"coordinates":67},[68,69],-90.07507,29.95465,{"lat":69,"lon":68},[72,76],{"name":73,"role":55,"phone":74,"phoneExt":10,"email":75},"Catherine Cammarata","504-568-4132","ccamma@lsuhsc.edu",{"name":77,"role":60,"phone":10,"phoneExt":10,"email":10},"Rebecca Lillis, MD",{"type":79,"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":91,"type":92},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.",[96,97,98,99,100,101,102,103,104,105,106,107,108],"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","2026-07-16",{"date":111,"type":112},"2026-07-20","ACTUAL",{"date":114,"type":112},"2026-06-03",{"date":116,"type":92},"2027-01",{"name":5,"class":6},2]