Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Safety and Efficacy Assessment of the VERTICA� - a Radio Frequency Device for the Treatment of Erectile Dysfunction
Brief 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.