[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569202":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":62,"collaborators":65,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":25,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CO2 Vaginal Laser treatment","EXPERIMENTAL","Laser treatment with a Fractional\u002FPixel CO2 laser (Femilift, Alma Lasers) will be performed with the following settings and procedure: single pulse; first pass 50-100 millijoules\u002Fpixel of energy, and 50-100 millijoules\u002Fpixel for the second pass. The energy level will be adjusted within the range based on the subject's comfort level. The same procedures will be followed for the sham group but no pulse will be generated.",[13],"Diagnostic Test: Optical coherence tomography (OCT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham - no vaginal laser treatment","SHAM_COMPARATOR","The vaginal laser probe will be placed as usual but no energy will be delivered to the tissue.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Optical coherence tomography (OCT)","The OCT device with cover will be used to take measurements at four areas in the vaginal canal: the proximal posterior aspect, proximal anterior, distal anterior, and distal posterior. The proximal and distal points will be marked on the OCT cover during the first set of measurements. Markings will be used to guide measurements during subsequent visits.",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"Felicia Lane, MD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Karla LORENTE, MD","CONTACT","714-798-9044","klorente@hs.uci.edu",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Nicole Wakida","949.824.3295","nwakida@hs.uci.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Beckman Laser Institute","RECRUITING","Irvine","California","92612","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-117.82311,33.66946,{"lat":53,"lon":52},[56,58,59],{"name":37,"role":33,"phone":38,"phoneExt":25,"email":57},"nwakida@uci.edu",{"name":28,"role":29,"phone":25,"phoneExt":25,"email":25},{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Karla Lorente, MD","SUB_INVESTIGATOR",{"type":29,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Felicia Lane","Division Director of Urogynecology",[66,69],{"name":67,"class":68},"Alma Lasers","INDUSTRY",{"name":70,"class":71},"National Institute for Biomedical Imaging and Bioengineering (NIBIB)","NIH","100569202","vaginal-changes-after-co2-laser-100569202",false,"NCT06691178","Vaginal Changes After CO2 Laser","Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT\u002FOCTA\u002FOCE Endoscopy, a Randomized Controlled Trial","OCTRCT","Inclusion Criteria:\n\n1. Birth sex: female\n2. Desire for vaginal laser therapy for GSM\n3. Age \\>=18 years old\n4. Willingness to forego other treatments for GSM within the study period\n5. Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)\n\nExclusion Criteria:\n\n1. History of pelvic radiation\n2. On hormone replacement therapy in the prior 3 months\n3. Not able or willing to follow study instructions\n4. Current diagnosis of recurrent UTIs",true,"FEMALE","18 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"NA","Genitourinary syndrome of menopause (GSM) occurs due to a decline in estrogen levels as a woman approaches menopause. The syndrome negatively impacts women's quality of life and is characterized by vaginal dryness, burning, diminished lubrication, painful intercourse and urinary symptoms such as frequency and urgency. GSM is diagnosed by symptom assessment and physical exam, with current mainstay of treatment being vaginal estrogen. Women with a history of breast cancer, gynecologic cancer, or venous thromboembolism may not be candidates for hormonal therapy. Thus, there has been a quest for effective non-hormonal forms of treatment for GSM. The use of vaginal CO2 laser treatment for GSM has shown promising results.\n\nIn this study, we aim to use long-wavelength optical coherence tomography\u002Fangiography\u002Felastography (OCT\u002FOCTA\u002FOCE) to document changes that occur in the vaginal epithelium during menopause as well as after treatment for GSM. OCT is a well-studied technology and is widely used in Dermatology and Ophthalmology. In collaboration with the Beckman Laser Institute (BLI), we have developed a non-invasive vaginal probe (HS# 2017-3686). The probe has subsequently been used in previous studies to validate measurements in the vaginal epithelium (HS# 2019-5446). A previous RCT compared clinical response to laser therapy to a control group that received a low level of laser therapy. The study also did not examine histology. This will be a randomized controlled trial in which women will be enrolled into one group receiving laser therapy and compared to a true sham group that will not receive laser therapy at all. Response will be measured primarily by OCT device as well as optional vaginal biopsies. There will also be questionnaires and exam of the vaginal tissue using the VHI.",[91],"Genitourinary Syndrome of Menopause","2026-02-16",{"date":94,"type":95},"2026-02-18","ACTUAL",{"date":97,"type":95},"2023-05-01",{"date":99,"type":85},"2027-07-01",{"name":5,"class":6},1]