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

Recruiting N/A Interventional Study
Erectile Dysfunction Following Radical Prostatectomy
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
30 – 75
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Comphya Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery; * Cancer stage T1c and T2a; * Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion o…
Contacts

Rana Harb

410-502-5500

rharb1@jhmi.edu

CONTACT