[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567816":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":134,"collaborators":136,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":35,"enrollmentInfo":150,"targetDuration":35,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":35,"overallStatus":43,"whyStopped":35,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"SoLa Pelvic Therapy","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaginal photobiomodulation","ACTIVE_COMPARATOR","Vaginal photobiomodulation with near-infrared (810-980nm wavelength) energy.",[13],"Device: SoLa Pelvic Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham-Light without laser energy.","SHAM_COMPARATOR","Vaginal light therapy without focused laser energy.",[13],[20],{"type":21,"name":5,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","SoLa Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 5-8 W for 3-6 minutes and delivers a fluence of 3,000 and 5,000 J\u002Fcm2 through a sterile vaginal probe. Specific treatment time is calculated based on vaginal length. Based on a code input, the device can cycle between emitting laser energy or sham which is visible light without focused laser energy.",[15,9],[25],"Low level laser therapy",[27],{"name":28,"affiliation":29,"role":30},"Georgine Lamvu, MD, MPH","SoLá Pelvic Therapy","PRINCIPAL_INVESTIGATOR",[32,37],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","833-608-6423",null,"georgine@solapelvictherapy.com",{"name":38,"role":33,"phone":35,"phoneExt":35,"email":39},"Pilar Garcia, MD","pilar@solatherapy.com",[41,64,82,99,117],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Obgyn South","RECRUITING","Birmingham","Alabama","35209","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-86.80249,33.52066,{"lat":53,"lon":52},[56,60,63],{"name":57,"role":33,"phone":58,"phoneExt":35,"email":59},"Alexander Childs, MD","(205) 397-9000","achilds@obgynsouth.com",{"name":61,"role":33,"phone":62,"phoneExt":35,"email":36},"Georgine Lamvu, MD","407-461-1189",{"name":57,"role":33,"phone":35,"phoneExt":35,"email":35},{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The Orady Womens Clinic","NOT_YET_RECRUITING","San Francisco","California","94109",{"type":50,"coordinates":71},[72,73],-122.41942,37.77493,{"lat":73,"lon":72},[76,80,81],{"name":77,"role":33,"phone":78,"phoneExt":35,"email":79},"Mona Orady, MD","(415)500-8133","oradymd@outlook.com",{"name":61,"role":33,"phone":62,"phoneExt":35,"email":36},{"name":77,"role":33,"phone":35,"phoneExt":35,"email":35},{"facility":83,"status":43,"city":84,"state":85,"zip":86,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Urogynecology of Kansas City","Overland Park","Kansas","66214",{"type":50,"coordinates":88},[89,90],-94.67079,38.98223,{"lat":90,"lon":89},[93,97,98],{"name":94,"role":33,"phone":95,"phoneExt":35,"email":96},"Charles Butrick, MD","(913)262-3000","cwbutrick@gmail.com",{"name":61,"role":33,"phone":62,"phoneExt":35,"email":36},{"name":94,"role":33,"phone":35,"phoneExt":35,"email":35},{"facility":100,"status":66,"city":101,"state":102,"zip":103,"country":47,"countryCode":48,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Boston Urogyn","Boston","Massachusetts","02481",{"type":50,"coordinates":105},[106,107],-71.05977,42.35843,{"lat":107,"lon":106},[110,114,115],{"name":111,"role":33,"phone":35,"phoneExt":112,"email":113},"Neeraj Kohli, MD","(617) 340-6446","nkohli@bostonurogyn.com",{"name":61,"role":33,"phone":62,"phoneExt":35,"email":36},{"name":116,"role":33,"phone":35,"phoneExt":35,"email":35},"Neeraj Kholi, MD",{"facility":118,"status":43,"city":119,"state":120,"zip":121,"country":47,"countryCode":48,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Nurture Women's Health","Frisco","Texas","75035",{"type":50,"coordinates":123},[124,125],-96.82361,33.15067,{"lat":125,"lon":124},[128,132,133],{"name":129,"role":33,"phone":130,"phoneExt":35,"email":131},"Angela Stoehr, MD","(972) 406-9911","angelastoehrmd@gmail.com",{"name":61,"role":33,"phone":62,"phoneExt":35,"email":36},{"name":129,"role":33,"phone":35,"phoneExt":35,"email":35},{"type":135,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[137],{"name":138,"class":139},"Uroshape LLC","UNKNOWN","100567816","phase-2-vaginal-photobiomodulation-for-chronic-pelvic-pain-100567816",false,"NCT06673108","Vaginal Photobiomodulation for Chronic Pelvic Pain","Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial","VOICE","Inclusion Criteria:\n\n1. Age 18 years or older;\n2. CPP for 3 months or longer;\n3. Overall pelvic pain severity ≥4 in the last 7 days;\n4. Pelvic muscle tenderness pain level ≥4.\n\nExclusion Criteria:\n\n1. Previous vaginal or vulvar laser therapy;\n2. Receiving concurrent pelvic physical therapy;\n3. Unable to tolerate vaginal\u002Fpelvic examination\n4. Taking drugs that have heat- or light- sensitive contraindications;\n5. Subjectively reports abnormal or decreased sensation in the vagina or rectum;\n6. History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;\n7. History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;\n8. History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;\n9. Less than 6 months post-partum;\n10. Actively trying to get pregnant or not willing to use contraception during the trial;\n11. Positive pregnancy test or planning to get pregnant during the study;\n12. Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; \\*\n13. Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;\n14. Does not speak, read, or writes English and thus cannot complete surveys;\n15. Does not have access to smart digital devices or computer, or cannot receive emails.","FEMALE","18 Years",{"count":151,"type":152},126,"ESTIMATED","INTERVENTIONAL",[155],"PHASE2","The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.",[158,159],"Chronic Pelvic Pain","Chronic Pelvic Pain Syndrome (CPPS)","2024-11-01",{"date":162,"type":163},"2024-11-04","ACTUAL",{"date":165,"type":163},"2024-10-17",{"date":167,"type":152},"2026-06",{"name":5,"class":6},5]