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

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.

NCT Number	NCT06968494
Lead Sponsor	Comphya Inc.
Conditions	Erectile Dysfunction Following Radical Prostatectomy
Enrollment	20 participants
Start Date	2025-06-05
Primary Completion	2027-04 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2025-11-10