[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528973":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":158,"collaborators":11,"id":160,"slug":11,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":11,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":11,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"OHH-MED Medical Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active","EXPERIMENTAL",null,[13],"Device: VERTICA Active 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States",{"type":44,"coordinates":45},"Point",[46,47],-117.92895,33.61891,{"lat":47,"lon":46},[50,54],{"name":51,"role":32,"phone":52,"phoneExt":11,"email":53},"Elia Abou Chawareb","714-456-7005","eaboucha@hs.uci.edu",{"name":55,"role":56,"phone":11,"phoneExt":11,"email":11},"Faysal Yafi, Yafi","PRINCIPAL_INVESTIGATOR",{"facility":58,"status":38,"city":59,"state":40,"zip":60,"country":42,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"San Diego Sexual Medicine","San Diego","92120",{"type":44,"coordinates":62},[63,64],-117.16472,32.71571,{"lat":64,"lon":63},[67,71],{"name":68,"role":32,"phone":69,"phoneExt":11,"email":70},"Sue Goldstein","619-265-8865","suewgoldstein@gmail.com",{"name":72,"role":56,"phone":11,"phoneExt":11,"email":11},"Irwin Goldstein, MD",{"facility":74,"status":38,"city":75,"state":76,"zip":77,"country":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Optimal Health 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Hanfling","202-888-6731","research@rachelrubinmd.com",{"name":117,"role":32,"phone":11,"phoneExt":11,"email":115},"Fiona Wardrop",{"name":119,"role":56,"phone":11,"phoneExt":11,"email":11},"Rachel Rubin, MD",{"facility":121,"status":38,"city":122,"state":123,"zip":124,"country":42,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":44,"coordinates":126},[127,128],-81.69541,41.4995,{"lat":128,"lon":127},[131,135,139],{"name":132,"role":32,"phone":133,"phoneExt":11,"email":134},"Lauren Grimm","216-444-4650","GRIMML@ccf.org",{"name":136,"role":32,"phone":137,"phoneExt":11,"email":138},"Carmen Czich","216-444-5081","Czichc@CCF.org",{"name":140,"role":56,"phone":11,"phoneExt":11,"email":11},"Petar Bajic, MD",{"facility":142,"status":38,"city":143,"state":144,"zip":145,"country":42,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Baylor College of Medicine","Houston","Texas","77030",{"type":44,"coordinates":147},[148,149],-95.36327,29.76328,{"lat":149,"lon":148},[152,156],{"name":153,"role":32,"phone":154,"phoneExt":11,"email":155},"Haarika Gudlavalleti","832-474-8009","Haarika.Gudlavalleti@bcm.edu",{"name":157,"role":56,"phone":11,"phoneExt":11,"email":11},"Mohit Khera, MD",{"type":159,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100528973",false,"NCT06167733","Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED","Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction","Inclusion Criteria:\n\n* Adult, heterosexual, males between 22 and 85 years of age\n* Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).\n* Subjects with an IIEF-EF score between 11-21\n* Steady relationship for at least 3 months\n* Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month\n* Subject is willing to sign informed consent and follow study protocol procedures\n* Subject has a smartphone\n\nExclusion Criteria:\n\n* Castrate and late onset hypogonadism\n* History of Priapism or Peyronie's Disease\n* Surgery or radiotherapy of the pelvic region\n* Anatomic penile deformations or penile prosthesis\n* Treatment with antiandrogens\n* Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)\n* History of urothelial or colorectal cancer\n* Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy\n* Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days\n* Subjects who are taking anticoagulation or anti-platelet therapy\n* History of psychiatric disorders, premature ejaculation and drug or alcohol abuse\n* Subjects who are incarcerated\n* Subjects who are cognitively challenged\n* Serious heart or lung disease\n* Pregnant partner",true,"MALE","22 Years","85 Years",{"count":171,"type":172},98,"ESTIMATED","INTERVENTIONAL",[175],"NA","Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.",[178],"Erectile Dysfunction","2026-02-11",{"date":181,"type":182},"2026-02-13","ACTUAL",{"date":184,"type":182},"2023-11-29",{"date":186,"type":172},"2026-10-01",{"name":5,"class":6},7]