[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"OHH-MED Medical Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100528973","safety-and-efficacy-of-the-vertica-rf-device-for-the-treatment-of-ed-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":21,"type":22},98,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Erectile Dysfunction","RECRUITING","2026-02-11",{"date":32,"type":33},"2026-02-13","ACTUAL",{"date":35,"type":33},"2023-11-29",{"date":37,"type":22},"2026-10-01",{"name":39,"class":40},"OHH-MED Medical Ltd","INDUSTRY",7,""]