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VERTICA® RF Device for Erectile Dysfunction

This study is testing the safety and effectiveness of the VERTICA® RF Device for men with mild to moderate erectile dysfunction (ED). You might be able to join if you are a man between 22 and 85 years old, have been diagnosed with ED for at least three months, and have a steady relationship. The study aims to see if the VERTICA Active device can significantly improve erectile function scores after 12 weeks compared to a VERTICA Sham device (which uses a non-therapeutic energy level). The study is currently recruiting 201 participants, but its exact status is unclear.

Study design
This interventional study will enroll 201 participants who will be randomly assigned to receive either the VERTICA Active device or the VERTICA Sham device.
What's involved
You will have an initial treatment session in a clinic to learn how to use the device, followed by 6 months of home use. You will be instructed to attempt sexual activity periodically.
Compensation
Not stated in the trial record.
Follow-up
The primary effectiveness of the device will be measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06167733

Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Active, Not Recruiting
NAAges 22–85InterventionalTreatment
OHH-MED Medical Ltd
~201 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:VERTICA Active deviceVERTICA Sham device

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 12 weeks
+1 more outcome measured

Conditions

Erectile Dysfunction

Explore related trials

Erectile Dysfunction

Where it's being run

6 sites across 5 states
California2
Florida1
Maryland1
Ohio1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.12 weeks

    The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.

  • 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.12 weeks

    The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.