Actively Recruiting
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Led by Comphya Inc. · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged between 30 and 75 years scheduled for nerve-sparing prostatectomy surgery
- Diagnosed with prostate cancer stage T1c or T2a
- Grade Groups 1 and 2, or low volume Grade Group 3 (Gleason score 4 + 3 = 7) with 2 or fewer biopsy cores or single MRI lesion
- IIEF-15 erectile function domain score of 26 or greater
- Interested in reducing erectile function impact after prostatectomy
- Able to read and understand patient materials and willing to sign consent
You will not qualify if you...
- History of neurological disease, including spinal cord injury or trauma
- IIEF-15 erectile function domain score below 26
- Inadequate nocturnal erectile function before prostatectomy
- PSA level greater than 20 ng/mL
- History of erectile dysfunction, priapism, or Peyronie disease
- Previous pelvic surgery, trauma, or radiation therapy
- Currently have an active implantable device
- Diagnosed with neurological degenerative diseases affecting erectile function
- Technical or clinical inability to use nerve-sparing techniques during surgery
- Unable to understand or use the device instructions
- Insulin-dependent diabetes with peripheral neuropathy or related complications
- Unwilling to engage in sexual activity
- Currently participating in another clinical trial contraindicating device implantation
- Participated in any drug or device trial in the last 4 weeks or plans to join another within 24 months
- Other conditions that increase risk or impair study data collection as judged by the investigator
- Member of vulnerable populations lacking consent capacity, such as mentally ill, prisoners, cognitively impaired, or employee volunteers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
R
Rana Harb
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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