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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: VERTICA Active device; Device: VERTICA Sham device

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahava Stein; Phone Number: 1-888-443-3867; Email: ahava@asteinrac.com

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92660
      • Recruiting
      • University of California, Irvine Medical Center
      • Contact: Faysal Yafi, MD; Phone Number: 714-456-7005; Email: fyafi@hs.uci.edu
      • Contact: Elia Abou Chawareb; Phone Number: (714) 456-7005; Email: eaboucha@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Device: VERTICA Active device; VERTICA device with a therapeutic RF energy level
Sham Comparator: Sham	Device: VERTICA Sham device; VERTICA device with a low, non-therapeutic RF energy level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: OHH-MED Medical Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: URN-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes