NCT06167733

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: OHH-MED Medical Ltd · Industry
• Sex: Male
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-29
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2023-12-12
• Last updated: 2026-02-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study