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New home device aims to treat erectile dysfunction without drugs

NCT ID NCT06167733

Symptom relief Sponsor: OHH-MED Medical Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests a device called VERTICA® that uses radio frequency energy to treat erectile dysfunction (ED). About 98 men with mild to moderate ED will use the device at home for 6 months, either the real device or a sham version. The goal is to see if the device improves erectile function safely compared to no treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

201 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 85 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Optimal Health Miami

    Aventura, Florida, 33180, United States

  • Rachel Rubin MD

    Bethesda, Maryland, 20814, United States

  • San Diego Sexual Medicine

    San Diego, California, 92120, United States

  • University of California, Irvine Medical Center

    Newport Beach, California, 92660, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.