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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

22 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine Medical Center, Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VERTICA Active device

Device

VERTICA device with a therapeutic RF energy level

VERTICA Sham device

Device

VERTICA device with a low, non-therapeutic RF energy level

Primary outcomes

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.

Time frame: 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.

Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

OHH-MED Medical Ltd

Industry

Registry information

Official study title

Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Dec 12, 2023
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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