[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516631":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":34,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active laser group","EXPERIMENTAL","In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt.",[13],"Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham laser group","SHAM_COMPARATOR","In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy","The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Sine Jacobsen, MD","CONTACT","+4578421069","sinjac@rm.dk",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":25},"Pinar Bor",[35],{"facility":36,"status":37,"city":38,"state":25,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Obstetrics and Gynaecology, Randers Regional Hospital","RECRUITING","Randers","8930","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],10.03639,56.4607,{"lat":46,"lon":45},[49,51],{"name":50,"role":29,"phone":25,"phoneExt":25,"email":31},"Sine Jacobsen",{"name":25,"role":29,"phone":30,"phoneExt":25,"email":25},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100516631","vaginal-co2-laser-therapy-for-genitourinary-syndrome-in-breast-cancer-survivors-100516631",false,"NCT06007027","Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors","Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study","Inclusion Criteria:\n\n* Breast cancer survivor in endocrine therapy\n* Symptomatic genitourinary symdrom of menopause with vaginal discomfort and\u002For dyspareunia\n* Able to read and understand Danish\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system\n* Use of non-hormonal\u002Fhormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)\n* Use of Chemotherapy (6 months prior to the baseline visit)\n* Acute urinary tract infection or active genital infection\n* History of vaginal reconstructive surgery","FEMALE","18 Years","100 Years",{"count":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69],"NA","This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.",[72],"Genitourinary Syndrome of Menopause",[74,75],"laser","mamma cancer","2024-12-04",{"date":78,"type":79},"2024-12-05","ACTUAL",{"date":81,"type":79},"2024-12-01",{"date":83,"type":66},"2026-03-30",{"name":5,"class":6},1]