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RECRUITING
NCT06167733
NA

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

Sponsor: OHH-MED Medical Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

VERTICA Active device

VERTICA device with a therapeutic RF energy level

DEVICE

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