[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100215766":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":19,"locations":29,"responsibleParty":52,"collaborators":54,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":19,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":19,"overallStatus":77,"whyStopped":19,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"El. En. SpA","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Laser Treatment","EXPERIMENTAL",[12],"Device: Laser treatment",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Laser treatment","The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece",[9],null,[21,25],{"name":22,"affiliation":23,"role":24},"Mickey Karram, MK","Hospital Physician, The Christ Hospital","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":28},"Eric Sokol, MD","Stanford University","STUDY_DIRECTOR",[30,42],{"facility":27,"status":19,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":19},"Palo Alto","California","94306","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-122.14302,37.44188,{"lat":40,"lon":39},{"facility":43,"status":19,"city":44,"state":45,"zip":46,"country":34,"countryCode":35,"cosmosGeoPoint":47,"geoPoint":51,"contacts":19},"The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital","West Chester","Ohio","45069",{"type":37,"coordinates":48},[49,50],-84.40716,39.33172,{"lat":50,"lon":49},{"type":53,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[55,58],{"name":56,"class":57},"The Christ Hospital","OTHER",{"name":27,"class":57},"100215766","clinical-investigation-to-assess-the-safety-and-efficacy-of-the-laser-for-the-treatment-of-vulvovaginal-atrophy-100215766",true,"NCT02085980","Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy","Inclusion Criteria:\n\n* Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months\n* Exhibiting VVA symptoms\n* Prolapse staged \\\u003C II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system\n* Have not had procedures in the anatomical area through 6 months prior to treatment\n* Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits\n\nExclusion Criteria:\n\n* • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).\n\n  * Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system\n  * Any serious disease, or chronic condition, that could interfere with the study compliance\n  * Previously undergone reconstructive pelvic surgery\n  * Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months\n  * A history of thrombophlebitis\n  * A history of acute infections\n  * A history of heart failure\n  * Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment\n  * Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study\n  * Taking medications that are photosensitive\n  * A history of keloid formation","FEMALE","45 Years","60 Years",{"count":69,"type":70},30,"ACTUAL","INTERVENTIONAL",[73],"NA","The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).",[76],"Vulvovaginal Atrophy","COMPLETED","2021-05-11",{"date":80,"type":70},"2021-06-04",{"date":82,"type":19},"2014-03",{"date":84,"type":70},"2015-11",{"name":5,"class":6},2]