BridgeMD
Tests treatment safety and results for Erectile Dysfunction
Official title Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
ClinicalTrials.gov ID: NCT06167733
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85, men only. Healthy volunteers may be eligible.
You may be able to join if
- Adult, heterosexual, males between 22 and 85 years of age
- people diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in...
- people 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
You likely can't join 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...
See the full eligibility criteria
- Adult, heterosexual, males between 22 and 85 years of age
- people 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).
- people 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
- 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
- people who are taking anticoagulation or anti-platelet therapy
- History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
- people who are incarcerated
- people who are cognitively challenged
- Serious heart or lung disease
- Pregnant partner
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- San Diego, California, United States
- Aventura, Florida, United States
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 22 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; San Diego, California, United States; Aventura, Florida, United States; Chicago, Illinois, United States; Bethesda, Maryland, United States; Cleveland, Ohio, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.