RecruitingNot ApplicableNCT05650866

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


Sponsor

Comphya Australia

Enrollment

20 participants

Start Date

May 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Activation of pro-erectile nerves within the pelvic plexus for people with erectile dysfunction following radical prostatectomy. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActivation 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.


Locations(4)

St. Vincent's Private Hospital

Fitzroy, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Australian Prostate Centre

North Melbourne, Victoria, Australia

Epworth HealthCare

Richmond, Victoria, Australia

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NCT05650866


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