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.
At a Glance
- Age
- 30 – 75
- Sex
- Male
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Comphya Inc. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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