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

Launched by OHH-MED MEDICAL LTD · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of the VERTICA® RF device for treating erectile dysfunction (ED) in adult men. If you are a heterosexual male between the ages of 22 and 85 and have been diagnosed with mild to moderate ED for at least three months, you might be eligible to participate. Other requirements include having a steady partner, being sexually active, and having a smartphone.

Participants will be randomly assigned to either receive the actual VERTICA® treatment or a placebo (a sham treatment that doesn't have any real effect). The study lasts for six months, during which participants will use the device at home and record their sexual activity. They will have monthly check-ins to monitor safety and effectiveness. If you're considering joining this trial, it could be a chance to explore a new treatment option while contributing to important research.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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