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

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 19, 2023

Primary Completion Date

May 19, 2025

Study Completion Date

May 19, 2025

Conditions
Erectile Dysfunction Following Radical Prostatectomy
Interventions
DEVICE

Activation of pro-erectile nerves within the pelvic plexus

The study device is an active implantable device. The device activates the cavernous nerves by delivering electrical pulses, to trigger an on-demand erection. The daily delivery of electrical pulses to the cavernous nerves will also allow participants to recover natural erectile function.

Trial Locations (4)

3050

ACTIVE_NOT_RECRUITING

Royal Melbourne Hospital, Melbourne

3051

RECRUITING

Australian Prostate Centre, North Melbourne

3065

ACTIVE_NOT_RECRUITING

St. Vincent's Private Hospital, Fitzroy

3121

ACTIVE_NOT_RECRUITING

Epworth HealthCare, Richmond

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Comphya Australia

INDUSTRY