Status:
RECRUITING
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Lead Sponsor:
OHH-MED Medical Ltd
Conditions:
Erectile Dysfunction
Eligibility:
MALE
22-85 years
Phase:
NA
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 Activ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2025
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06167733
Start Date
November 29 2023
End Date
October 28 2025
Last Update
September 5 2025
Active Locations (7)
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1
University of California, Irvine Medical Center
Newport Beach, California, United States, 92660
2
San Diego Sexual Medicine
San Diego, California, United States, 92120
3
Optimal Health Miami
Aventura, Florida, United States, 33180
4
The University of Chicago
Chicago, Illinois, United States, 60637