NCT06968494

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Comphya Inc. · Industry
• Sex: Male
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

Conditions

• Erectile Dysfunction Following Radical Prostatectomy

Interventions

Type	Name	Description
DEVICE	Activation of pro-erectile nerves within the pelvic plexus	The study device is an active implantable device. The device activates the pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function.

Timeline

• Start date: 2025-06-05
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-05-13
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study