Clinical trial NCT06167733: Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Official title: Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: OHH-MED Medical Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-12
Enrollment: 98
Sex: MALE
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active vs. Sham
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: A significant difference in the mean change from baseline in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, between the treatment groups.
timeFrame: 12 weeks
measure: A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Aventura
country: United States
facility: Optimal Health Miami
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Bethesda
country: United States
facility: Rachel Rubin MD
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: