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

Last updated: February 27, 2025
Sponsor: OHH-MED Medical Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Impotence

Infertility

Male Hormonal Deficiencies/abnormalities

Treatment

VERTICA Active device

VERTICA Sham device

Clinical Study ID

NCT06167733
URN-2022
  • Ages 22-85
  • Male
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 AmericanUrology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 ofthe 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 6times a month

  • Subject is willing to sign informed consent and follow study protocol procedures

  • Subject has a smartphone

Exclusion

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 beamradiation 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 intermittentcatheterization (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

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: VERTICA Active device
Phase:
Study Start date:
November 29, 2023
Estimated Completion Date:
July 28, 2025

Connect with a study center

  • University of California, Irvine Medical Center

    Newport Beach, California 92660
    United States

    Completed

  • San Diego Sexual Medicine

    San Diego, California 92120
    United States

    Active - Recruiting

  • Optimal Health Miami

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.