Actively Recruiting
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Led by OHH-MED Medical Ltd · Updated on 2026-02-13
98
Participants Needed
7
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult, heterosexual, males between 22 and 85 years of age
- Diagnosed with organic ED for at least 3 months
- IIEF-EF score between 11 and 21
- In a steady relationship for at least 3 months
- Sexually active with at least weekly intercourse attempts or 6 times a month
- Willing to sign informed consent and follow study procedures
- Has a smartphone
You will not qualify if you...
- Castrate and late onset hypogonadism
- History of priapism or Peyronie's disease
- Surgery or radiotherapy in the pelvic region
- Anatomic penile deformities or penile prosthesis
- Treatment with antiandrogens
- Previous whole gland prostate treatment (e.g., cryoablation, HIFU, radiation, prostatectomy)
- History of urothelial or colorectal cancer
- Major neurological conditions (Alzheimer's, Parkinson's, MS, ALS, spinal cord injury, pelvic neuropathy)
- Neurogenic bladder or recent catheter use
- Taking anticoagulant or anti-platelet therapy
- History of psychiatric disorders, premature ejaculation, or substance abuse
- Incarceration
- Cognitive impairment
- Serious heart or lung disease
- Partner is pregnant
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of California, Irvine Medical Center
Newport Beach, California, United States, 92660
Actively Recruiting
2
San Diego Sexual Medicine
San Diego, California, United States, 92120
Actively Recruiting
3
Optimal Health Miami
Aventura, Florida, United States, 33180
Actively Recruiting
4
The University of Chicago
Chicago, Illinois, United States, 60637
Withdrawn
5
Rachel Rubin MD
Bethesda, Maryland, United States, 20814
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ahava Stein
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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