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

NCT06167733 | Active Not Recruiting FDA Device

• 1 other identifier: URN-2022
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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.

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

  12 weeks

• 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.

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

  12 weeks

Study Arms (2)

Active

EXPERIMENTAL

Device: VERTICA Active device

Sham

SHAM COMPARATOR

Device: VERTICA Sham device

Interventions

VERTICA Active device DEVICE

VERTICA device with a therapeutic RF energy level

Active

VERTICA Sham device DEVICE

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

Sham

Eligibility Criteria

• Age: 22 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHH-MED Medical Ltd: lead

Study Sites (6)

University of California, Irvine Medical Center

Newport Beach, California, 92660, United States

Location

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Optimal Health Miami

Aventura, Florida, 33180, United States

Location

Rachel Rubin MD

Bethesda, Maryland, 20814, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study personnel, including the investigator and raters and study subjects will be blinded to the treatment assignment (active vs. sham)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active vs. Sham

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (6)