[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528973":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":159,"collaborators":11,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":11,"eligibilityCriteria":167,"healthyVolunteers":168,"sex":169,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":11,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"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 device",{"label":15,"type":16,"description":11,"interventionNames":17},"Sham","SHAM_COMPARATOR",[18],"Device: VERTICA Sham device",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","VERTICA Active device","VERTICA device with a therapeutic RF energy level",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"VERTICA Sham device","VERTICA device with a low, non-therapeutic RF energy level",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Ahava Stein","CONTACT","1-888-443-3867","ahava@asteinrac.com",[36,58,74,91,102,121,142],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of California, Irvine Medical Center","RECRUITING","Newport Beach","California","92660","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.92895,33.61891,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":11,"email":54},"Elia Abou Chawareb","714-456-7005","eaboucha@hs.uci.edu",{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Faysal Yafi, Yafi","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":38,"city":60,"state":40,"zip":61,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"San Diego Sexual Medicine","San Diego","92120",{"type":45,"coordinates":63},[64,65],-117.16472,32.71571,{"lat":65,"lon":64},[68,72],{"name":69,"role":32,"phone":70,"phoneExt":11,"email":71},"Sue Goldstein","619-265-8865","suewgoldstein@gmail.com",{"name":73,"role":57,"phone":11,"phoneExt":11,"email":11},"Irwin Goldstein, MD",{"facility":75,"status":38,"city":76,"state":77,"zip":78,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Optimal Health Miami","Aventura","Florida","33180",{"type":45,"coordinates":80},[81,82],-80.13921,25.95648,{"lat":82,"lon":81},[85,89],{"name":86,"role":32,"phone":87,"phoneExt":11,"email":88},"Sayonara Nunez","305-466-9000","sayo@optimalhealthmiami.com",{"name":90,"role":57,"phone":11,"phoneExt":11,"email":11},"Marc Gittelman, MD",{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":42,"countryCode":43,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"The University of Chicago","WITHDRAWN","Chicago","Illinois","60637",{"type":45,"coordinates":98},[99,100],-87.65005,41.85003,{"lat":100,"lon":99},{"facility":103,"status":38,"city":104,"state":105,"zip":106,"country":42,"countryCode":43,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Rachel Rubin MD","Bethesda","Maryland","20814",{"type":45,"coordinates":108},[109,110],-77.10026,38.98067,{"lat":110,"lon":109},[113,117,119],{"name":114,"role":32,"phone":115,"phoneExt":11,"email":116},"Sarina Hanfling","202-888-6731","research@rachelrubinmd.com",{"name":118,"role":32,"phone":11,"phoneExt":11,"email":116},"Fiona Wardrop",{"name":120,"role":57,"phone":11,"phoneExt":11,"email":11},"Rachel Rubin, MD",{"facility":122,"status":38,"city":123,"state":124,"zip":125,"country":42,"countryCode":43,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":45,"coordinates":127},[128,129],-81.69541,41.4995,{"lat":129,"lon":128},[132,136,140],{"name":133,"role":32,"phone":134,"phoneExt":11,"email":135},"Lauren Grimm","216-444-4650","GRIMML@ccf.org",{"name":137,"role":32,"phone":138,"phoneExt":11,"email":139},"Carmen Czich","216-444-5081","Czichc@CCF.org",{"name":141,"role":57,"phone":11,"phoneExt":11,"email":11},"Petar Bajic, MD",{"facility":143,"status":38,"city":144,"state":145,"zip":146,"country":42,"countryCode":43,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Baylor College of Medicine","Houston","Texas","77030",{"type":45,"coordinates":148},[149,150],-95.36327,29.76328,{"lat":150,"lon":149},[153,157],{"name":154,"role":32,"phone":155,"phoneExt":11,"email":156},"Haarika Gudlavalleti","832-474-8009","Haarika.Gudlavalleti@bcm.edu",{"name":158,"role":57,"phone":11,"phoneExt":11,"email":11},"Mohit Khera, MD",{"type":160,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":173,"type":174},98,"ESTIMATED","INTERVENTIONAL",[177],"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.",[180],"Erectile Dysfunction","2026-02-11",{"date":183,"type":184},"2026-02-13","ACTUAL",{"date":186,"type":184},"2023-11-29",{"date":188,"type":174},"2026-10-01",{"name":5,"class":6},7]