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Clinical Trials in the USA / NCT06167733
Active, not recruiting Not applicable

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

NCT06167733 · tracked via the Priya Life Science USA tracker
Sponsor
OHH-MED Medical Ltd
Phase
Not applicable
Started
2023-11-29
Last updated
2026-09-29

Condition(s) studied

Erectile Dysfunction

Investigational drug(s) / intervention(s)

VERTICA Active deviceVERTICA Sham device

VERTICA Active device: VERTICA device with a therapeutic RF energy level

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

Study 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. 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.

Eligibility

Sex
MALE
Min age
22 Years
Max age
85 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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.

Trial sites (6)

FacilityCityRegionStatus
University of California, Irvine Medical Center Newport Beach California
San Diego Sexual Medicine San Diego California
Optimal Health Miami Aventura Florida
Rachel Rubin MD Bethesda Maryland
Cleveland Clinic Cleveland Ohio
Baylor College of Medicine Houston Texas

Other trials for the same condition

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IT Matters: The Erectile Restoration Registry Enrolling by invitation
Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject Starting soon
The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06167733 on ClinicalTrials.gov ↗ ← All trials in the USA