Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT06167733
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study personnel, including the investigator and raters and study subjects will be blinded to the treatment assignment (active vs. sham)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active vs. Sham'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A significant difference in the mean change from baseline in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, between the treatment groups.', 'timeFrame': '12 weeks', 'description': 'The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.'}, {'measure': 'A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.', 'timeFrame': '12 weeks', 'description': 'The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '22 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "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"}, 'identificationModule': {'nctId': 'NCT06167733', 'briefTitle': 'Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED', 'organization': {'class': 'INDUSTRY', 'fullName': 'OHH-MED Medical Ltd'}, 'officialTitle': 'Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'URN-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'interventionNames': ['Device: VERTICA Active device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Device: VERTICA Sham device']}], 'interventions': [{'name': 'VERTICA Active device', 'type': 'DEVICE', 'description': 'VERTICA device with a therapeutic RF energy level', 'armGroupLabels': ['Active']}, {'name': 'VERTICA Sham device', 'type': 'DEVICE', 'description': 'VERTICA device with a low, non-therapeutic RF energy level', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sue Goldstein', 'role': 'CONTACT', 'email': 'suewgoldstein@gmail.com', 'phone': '619-265-8865'}, {'name': 'Irwin Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Diego Sexual Medicine', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sayonara Nunez', 'role': 'CONTACT', 'email': 'sayo@optimalhealthmiami.com', 'phone': '305-466-9000'}, {'name': 'Marc Gittelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Optimal Health Miami', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarina Hanfling', 'role': 'CONTACT', 'email': 'research@rachelrubinmd.com', 'phone': '202-888-6731'}, {'name': 'Fiona Wardrop', 'role': 'CONTACT', 'email': 'research@rachelrubinmd.com'}, {'name': 'Rachel Rubin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rachel Rubin MD', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Grimm', 'role': 'CONTACT', 'email': 'GRIMML@ccf.org', 'phone': '216-444-4650'}, {'name': 'Carmen Czich', 'role': 'CONTACT', 'email': 'Czichc@CCF.org', 'phone': '216-444-5081'}, {'name': 'Petar Bajic, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haarika Gudlavalleti', 'role': 'CONTACT', 'email': 'Haarika.Gudlavalleti@bcm.edu', 'phone': '832-474-8009'}, {'name': 'Mohit Khera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ahava Stein', 'role': 'CONTACT', 'email': 'ahava@asteinrac.com', 'phone': '1-888-443-3867'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHH-MED Medical Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}