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

Part of paid clinical trials in Newport Beach, California.

Sponsor
OHH-MED Medical Ltd
Study ID
NCT06167733
Status
Recruiting
Apply to this trial

Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
22 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • VERTICA Active device — DEVICE
    VERTICA device with a therapeutic RF energy level
  • VERTICA Sham device — DEVICE
    VERTICA device with a low, non-therapeutic RF energy level

Study Details

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.

Key Dates

Start date
Nov 29, 2023
Status verified
Feb 2026
Primary completion
Apr 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
  • Sham Comparator: Sham

Primary Outcome 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. [ Time Frame: 12 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Irvine Medical CenterNewport BeachCalifornia92660
Elia Abou Chawareb
[email protected]
714-456-7005
Faysal Yafi, Yafi (PRINCIPAL_INVESTIGATOR)
San Diego Sexual MedicineSan DiegoCalifornia92120
Sue Goldstein
[email protected]
619-265-8865
Irwin Goldstein, MD (PRINCIPAL_INVESTIGATOR)
Optimal Health MiamiAventuraFlorida33180
Sayonara Nunez
[email protected]
305-466-9000
Marc Gittelman, MD (PRINCIPAL_INVESTIGATOR)
The University of ChicagoChicagoIllinois60637-
Rachel Rubin MDBethesdaMaryland20814
Sarina Hanfling
[email protected]
202-888-6731
Fiona Wardrop
[email protected]
Rachel Rubin, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Lauren Grimm
[email protected]
216-444-4650
Carmen Czich
[email protected]
216-444-5081
Petar Bajic, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Haarika Gudlavalleti
[email protected]
832-474-8009
Mohit Khera, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newport Beach, CA

By research site
University of California, Irvine Medical Center· Newport Beach, CASan Diego Sexual Medicine· San Diego, CAOptimal Health Miami· Aventura, FLThe University of Chicago· Chicago, ILRachel Rubin MD· Bethesda, MDCleveland Clinic· Cleveland, OH

Related Studies