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First received: December 04, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Erectile Dysfunction

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…

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