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Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Sponsor: OHH-MED Medical Ltd
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.
Official title: Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction
Key Details
Gender
MALE
Age Range
22 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2023-11-29
Completion Date
2026-10-01
Last Updated
2026-02-13
Healthy Volunteers
Yes
Conditions
Interventions
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 (7)
University of California, Irvine Medical Center
Newport Beach, California, United States
San Diego Sexual Medicine
San Diego, California, United States
Optimal Health Miami
Aventura, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Rachel Rubin MD
Bethesda, Maryland, United States
Cleveland Clinic
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States