[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651238":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":205,"collaborators":25,"id":207,"slug":208,"hasResults":209,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":215,"sex":216,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":25,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},{"fullName":5,"class":6},"Mel Mont Medical","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"General Population Group","ACTIVE_COMPARATOR","1. Participants are 25 to 65 years of age and willing to provide informed consent.\n2. Participants have an intact cervix.",[13,14],"Diagnostic Test: Mia by XytoTest","Diagnostic Test: Rovers Cervex-Brush",{"label":16,"type":10,"description":17,"interventionNames":18},"Enriched Population Group","1. Participants are 25 to 65 years of age and willing to provide informed consent.\n2. Participants have an intact cervix.\n3. One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and\u002For presenting for colposcopy\u002FLEEP\u002Fexcisional intervention.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Mia by XytoTest","Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Rovers Cervex-Brush","Rovers Cervex-Brush is for physician collection of vaginal specimens.",[16,9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Liliana Montes","CONTACT","305 335 6162","l.montes@xytotest.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Rowena Schokman","301-641-3215","rschokman@mdcassoc.com",[41,60,75,90,104,118,133,148,162,175,190],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"ASR Arizona CGA","RECRUITING","Phoenix","Arizona","85004","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-112.07404,33.44838,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":58,"phoneExt":25,"email":59},"Reena Grewal","208-906-1600","reena@idahoasr.com",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Integrated Clinical Research","Sherman Oaks","California","91403",{"type":50,"coordinates":66},[67,68],-118.44925,34.15112,{"lat":68,"lon":67},[71],{"name":72,"role":33,"phone":73,"phoneExt":25,"email":74},"Iryna McCormick","818-861-0088","i.mccormick@icrsite.com",{"facility":76,"status":43,"city":77,"state":78,"zip":79,"country":47,"countryCode":48,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Altus Clinical Research","Lake Worth","Florida","33461",{"type":50,"coordinates":81},[82,83],-80.07231,26.61708,{"lat":83,"lon":82},[86],{"name":87,"role":33,"phone":88,"phoneExt":25,"email":89},"Stephanie Feliz","561-641-0404","sfeliz@altusresearch.com",{"facility":91,"status":43,"city":92,"state":78,"zip":93,"country":47,"countryCode":48,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Zenacare Research","North Miami Beach","33169",{"type":50,"coordinates":95},[96,97],-80.16255,25.93315,{"lat":97,"lon":96},[100],{"name":101,"role":33,"phone":102,"phoneExt":25,"email":103},"Paola Rothberg","305-902-3135","paola@zenacare.com",{"facility":105,"status":43,"city":106,"state":107,"zip":108,"country":47,"countryCode":48,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"ASR Idaho CGI","Boise","Idaho","83702",{"type":50,"coordinates":110},[111,112],-116.20345,43.6135,{"lat":112,"lon":111},[115],{"name":116,"role":33,"phone":58,"phoneExt":25,"email":117},"Stephanie Canning","stephaniec@idahoasr.com",{"facility":119,"status":43,"city":120,"state":121,"zip":122,"country":47,"countryCode":48,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Boeson Research - 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Participants are 25 to 65 years of age and willing to provide informed consent.\n2. Participants have an intact cervix.\n\nGroup 2: Enriched Population Group\n\n1. Participants are 25 to 65 years of age and willing to provide informed consent.\n2. Participants have an intact cervix.\n3. One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and\u002For presenting for colposcopy\u002FLEEP\u002Fexcisional intervention.\n\nExclusion Criteria:\n\nApply to all groups:\n\n1. Impaired decision-making capacity or inability to provide informed consent.\n2. History of partial or total hysterectomy, including removal of the cervix.\n3. Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).\n4. Current pregnancy (based on self-reporting).\n5. Active menstruation at time of specimen collection.\n6. Vaginal bleeding within 48 hours.\n7. Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.\n8. Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.\n9. Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.",true,"FEMALE","25 Years","65 Years",{"count":220,"type":221},260,"ESTIMATED","INTERVENTIONAL",[224],"NA","To evaluate whether individuals drawn from the intended use population can successfully interpret and follow the IFU for the Mia by XytoTest self-collection device and perform a vaginal sample collection yielding sufficient cellular material for primary hrHPV screening.\n\nTo assess the clinical performance of Mia self-collected vaginal specimens by evaluating agreement with paired clinician-collected cervical specimens for the detection of high-risk HPV, when both specimen types are analyzed using the cobas HPV Test (Roche Molecular Systems). Residual samples may be used to determine adequacy for additional assays that require vaginal and\u002For cervical specimens (such as mRNA E6 and E7 Biomarker Test, dual stain cytology).",[227,228],"HPV","HPV - Anogenital Human Papilloma Virus Infection",[230,231],"hrHPV","cobas HPV test","2026-08-06",{"date":234,"type":235},"2026-08-11","ACTUAL",{"date":237,"type":235},"2026-07-09",{"date":239,"type":221},"2026-09",{"name":5,"class":6},11]