[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494073":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":60,"collaborators":29,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":29,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":45,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Mona Lisa Touch CO2 laser","ACTIVE_COMPARATOR","1. Power: 30 W.\n2. Dwell time: 1000 μs.\n3. Spacing: 1000 μm.\n4. Depth: SmartStack parameter from 1 to 3 depending on the treatment status.\n5. D-pulse mode.\n6. At the introitus the power will be reduced to 24 W",[13],"Device: intravaginal laser",{"label":15,"type":10,"description":16,"interventionNames":17},"Fotona Smooth erbium:YAG laser","1. Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J\u002Fcm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm.\n2. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 10 J\u002Fcm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"sham treatment","SHAM_COMPARATOR","1. The blocking device is inserted over the laser outlet before attaching the application speculum. With this device the laser beam is blocked entirely.\n2. Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J\u002Fcm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm.\n3. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 1,5 J\u002Fcm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","intravaginal laser","application of intravaginal laser",[15,9,19],null,[31],{"name":32,"affiliation":33,"role":34},"Susanne Housmans, MD","UZ Leuven","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},"CONTACT","+3216332211","susanne.housmans@uzleuven.be",{"name":41,"role":37,"phone":38,"phoneExt":29,"email":42},"Jan Deprest, PhD","jan.deprest@uzleuven.be",[44],{"facility":33,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Leuven","Flemish Brabant","3000","Belgium","BE",{"type":52,"coordinates":53},"Point",[54,55],4.70093,50.87959,{"lat":55,"lon":54},[58,59],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},{"name":41,"role":37,"phone":38,"phoneExt":29,"email":42},{"type":61,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100494073","use-of-fractional-co2-laser-versus-erbiumyag-laser-for-the-treatment-of-gsm-in-patients-using-aromatase-inhibitors-100494073",false,"NCT05713435","Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors","Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.","LASI","Inclusion Criteria:\n\nRecruited participants will meet all of these criteria:\n\n* a history of breast cancer\n* premenopausal at diagnosis of breast cancer\n* using AI as an adjuvant treatment\n* moderate to severe symptoms of GSM (VAS ≥ 4\u002F10)\n* currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)\n\nExclusion Criteria:\n\n* Not willing to abstain from vaginal intercourse for 1 week following laser therapy\n* Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion\n* Use of hormonal therapy within 6 months prior to inclusion (systemic or local)\n* Acute urinary or genital tract infections\n* A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration\n* Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System\n* Previous vaginal mesh implantation\n* Abnormal result in the last cervical smear (maximum 36 month before enrollment)\n* Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)\n* Vaginal stenosis that does not allow the placement of the laser probe\n* Any condition that could interfere with study compliance","FEMALE","18 Years","100 Years",{"count":74,"type":75},162,"ESTIMATED","INTERVENTIONAL",[78],"NA","To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer",[81],"Genitourinary Syndrome of Menopause",[83,26,84,85],"genitourinary syndrome of menopause","breast cancer","aromatase inhibitor","2024-06-28",{"date":88,"type":89},"2024-07-01","ACTUAL",{"date":91,"type":89},"2022-12-27",{"date":93,"type":75},"2025-12",{"name":5,"class":6},1]