[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587825":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":71,"collaborators":20,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":20,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":20,"enrollmentInfo":82,"targetDuration":20,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Cern Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bacterial Vaginosis and Fungal Vaginitis","EXPERIMENTAL","For bacterial vaginosis, the participants receive 30-minute daily treatment with the Cern Device for 5 days. For fungal vaginitis, the participants receive 60-minute daily treatment with the Cern Device for 5 days.",[13],"Device: Cern Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Cern Device","The Cern Device is an Intravaginal device utilizing low level microbicidal visible light at a 450nm low level microbicidal light, in visible spectrum for treatment of vaginitis, including both bacterial vaginosis and fungal vaginitis.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Gregg Klang","CONTACT","(949) 306-7160","gklang@cerndevice.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Melanie Santos","(650) 353-6353","melaniesant@gmail.com",[32,51,61],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Akerman Med","RECRUITING","Irvine","California","92618","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-117.82311,33.66946,{"lat":44,"lon":43},[47],{"name":48,"role":24,"phone":49,"phoneExt":20,"email":50},"Allan Akerman, MD","714-914-9949","allan_akerman@yahoo.com",{"facility":33,"status":34,"city":52,"state":36,"zip":53,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Orange","92868",{"type":41,"coordinates":55},[56,57],-117.85311,33.78779,{"lat":57,"lon":56},[60],{"name":48,"role":24,"phone":49,"phoneExt":20,"email":50},{"facility":33,"status":34,"city":62,"state":36,"zip":63,"country":38,"countryCode":39,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Santa Ana","92707",{"type":41,"coordinates":65},[66,67],-117.86783,33.74557,{"lat":67,"lon":66},[70],{"name":48,"role":24,"phone":49,"phoneExt":20,"email":50},{"type":72,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100587825","clinical-protocol-cern-feasibility-study-100587825",false,"NCT06933420","Clinical Protocol CERN Feasibility Study","Feasibility\u002FFirst in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis","Inclusion Criteria:\n\n* Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis\n\nExclusion Criteria:\n\n* Postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.","FEMALE","18 Years",{"count":83,"type":84},9,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to learn if the intravaginal Cern device works to treat bacterial vaginosis and fungal vaginitis in premenopausal women. It will also learn about the safety of the device. The main questions it aims to answer are: Does the device accomplish symptom resolution and negative diagnostic tests post-treatment? What medical problems do participants have when using the intravaginal device? Participants will use the investigational intravaginal device for 5 consecutive days, participate in teleconferences and weekly follow-ups, attend in-clinic visits, and maintain a study diary.",[90,91],"Bacterial Vaginosis","Fungal Vaginal Infections","2025-04-10",{"date":94,"type":95},"2025-04-18","ACTUAL",{"date":97,"type":95},"2024-11-06",{"date":99,"type":84},"2025-05",{"name":5,"class":6},3]