Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
NCT ID: NCT06167733
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
98 participants
INTERVENTIONAL
2023-11-29
2025-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
VERTICA Active device
VERTICA device with a therapeutic RF energy level
Sham
VERTICA Sham device
VERTICA device with a low, non-therapeutic RF energy level
Interventions
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VERTICA Active device
VERTICA device with a therapeutic RF energy level
VERTICA Sham device
VERTICA device with a low, non-therapeutic RF energy level
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
85 Years
MALE
Yes
Sponsors
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OHH-MED Medical Ltd
INDUSTRY
Responsible Party
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Locations
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University of California, Irvine Medical Center
Newport Beach, California, United States
San Diego Sexual Medicine
San Diego, California, United States
Optimal Health Miami
Aventura, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Rachel Rubin MD
Bethesda, Maryland, United States
Cleveland Clinic
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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URN-2022
Identifier Type: -
Identifier Source: org_study_id
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