Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction
1 other identifier
interventional
98
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2023
CompletedFirst Submitted
Initial submission to the registry
December 4, 2023
CompletedFirst Posted
Study publicly available on registry
December 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedFebruary 13, 2026
February 1, 2026
2.3 years
December 4, 2023
February 11, 2026
Conditions
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
EXPERIMENTALSham
SHAM COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California, Irvine Medical Center
Newport Beach, California, 92660, United States
San Diego Sexual Medicine
San Diego, California, 92120, United States
Optimal Health Miami
Aventura, Florida, 33180, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Rachel Rubin MD
Bethesda, Maryland, 20814, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
Study Record Dates
First Submitted
December 4, 2023
First Posted
December 12, 2023
Study Start
November 29, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02