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

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.

Eligibility

Age range

22–85 years

Sex

Male

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

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