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Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
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.
Age
30 - 75 years
Sex
MALE
Healthy Volunteers
No
Johns Hopkins Hospital
Baltimore, Maryland, United States
Start Date
June 5, 2025
Primary Completion Date
April 1, 2027
Completion Date
April 1, 2027
Last Updated
November 10, 2025
20
ESTIMATED participants
Activation of pro-erectile nerves within the pelvic plexus
DEVICE
Lead Sponsor
Comphya Inc.
NCT06605508
NCT06458855
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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