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

Erectile Dysfunction Clinical Trial

Official title:

Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167733
• Other study ID #: URN-2022
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: OHH-MED Medical Ltd
• Contact: Ahava Stein
• Phone: 1-888-443-3867
• Email: ahava[@]asteinrac.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• VERTICA Active device
VERTICA device with a therapeutic RF energy level
• VERTICA Sham device
VERTICA device with a low, non-therapeutic RF energy level

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
OHH-MED Medical Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.	12 weeks
Primary	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.	The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.	12 weeks