NCT06299332

Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: InMode MD Ltd. · Industry
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Device treatment	20 heterosexual males clinically diagnosed with Erectile Dysfunction will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit

Timeline

• Start date: 2023-06-23
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2024-03-07
• Last updated: 2024-03-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study