Erectile DysfunctionNCT06167733
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
A study testing VERTICA Active device in people with Erectile Dysfunction, run by OHH-MED Medical Ltd at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- VERTICA Active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Nov 2023to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Optimal Health Miami
Aventura, Florida, 33180
Rachel Rubin MD
Bethesda, Maryland, 20814
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
University of California, Irvine Medical Center
Newport Beach, California, 92660
San Diego Sexual Medicine
San Diego, California, 92120
About this study
Official title: Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction
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
- Erectile Dysfunction
- Being tested
- VERTICA Active device, VERTICA Sham device
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERTICA Active deviceDevice
VERTICA device with a therapeutic RF energy level
VERTICA Sham deviceDevice
VERTICA device with a low, non-therapeutic RF energy level
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Device: VERTICA Active device |
| Sham | Sham comparator | Not described Receives: Device: VERTICA Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.
Measured: 12 weeks
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.
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start29 Nov 2023
- Primary completion21 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active vs. Sham
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHH-MED Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167733
- Sponsor's protocol ID
- URN-2022
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes