Using the VERTICA® RF Device to treat erectile dysfunction
Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction
NA · OHH-MED Medical Ltd · NCT06167733
This study is testing whether the VERTICA® RF device can help adult men with mild to moderate erectile dysfunction improve their condition over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 22 Years to 85 Years |
| Sex | Male |
| Sponsor | OHH-MED Medical Ltd (industry) |
| Drugs / interventions | radiation |
| Locations | 7 sites (Newport Beach, California and 6 other locations) |
| Trial ID | NCT06167733 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of the VERTICA® RF device in treating adult males with mild to moderate erectile dysfunction (ED). Participants will be randomly assigned to receive either the active VERTICA treatment or a sham device, with a total treatment duration of six months. Baseline assessments will include demographic data and medical history, followed by monthly follow-ups to monitor safety and efficacy. Patients will also log their sexual activity attempts throughout the study to assess the device's impact on their condition.
Who should consider this trial
Good fit: Ideal candidates are heterosexual males aged 22 to 85 with a diagnosis of organic erectile dysfunction and a stable sexual relationship.
Not a fit: Patients with conditions such as hypogonadism, penile deformities, or a history of certain pelvic surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for men suffering from erectile dysfunction.
How similar studies have performed: While similar approaches have been explored, the specific use of the VERTICA® RF device represents a novel intervention in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult, heterosexual, males between 22 and 85 years of age * 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). * Subjects with an IIEF-EF score between 11-21 * Steady relationship for at least 3 months * Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month * Subject is willing to sign informed consent and follow study protocol procedures * Subject has a smartphone Exclusion Criteria: * Castrate and late onset hypogonadism * History of Priapism or Peyronie's Disease * Surgery or radiotherapy of the pelvic region * Anatomic penile deformations or penile prosthesis * Treatment with antiandrogens * Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.) * History of urothelial or colorectal cancer * Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy * Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days * Subjects who are taking anticoagulation or anti-platelet therapy * History of psychiatric disorders, premature ejaculation and drug or alcohol abuse * Subjects who are incarcerated * Subjects who are cognitively challenged * Serious heart or lung disease * Pregnant partner
Where this trial is running
Newport Beach, California and 6 other locations
- University of California, Irvine Medical Center — Newport Beach, California, United States (RECRUITING)
- San Diego Sexual Medicine — San Diego, California, United States (RECRUITING)
- Optimal Health Miami — Aventura, Florida, United States (RECRUITING)
- The University of Chicago — Chicago, Illinois, United States (WITHDRAWN)
- Rachel Rubin MD — Bethesda, Maryland, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- Baylor College of Medicine — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Ahava Stein
- Email: ahava@asteinrac.com
- Phone: 1-888-443-3867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Erectile Dysfunction