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

Ohh-Med Medical

Status

Enrolling

Conditions

Erectile Dysfunction

Treatments

Device: VERTICA Active device

Device: VERTICA Sham device

Study type

Interventional

Funder types

Industry

Identifiers

NCT06167733

URN-2022

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

Male

Ages

22 to 85 years old

Volunteers

Accepts Healthy Volunteers

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