Status:
RECRUITING
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Lead Sponsor:
Comphya Inc.
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
30-75 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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 of GG3 disease;
- IIEF-15 erectile function domain score equal to or greater than 26;
- Men interested in minimizing the effect of radical prostatectomy on erectile function;
- Ability to read and understand patient information materials and willingness to sign a written informed consent.
Exclusion
- Men with neurological disease, including a history of spinal cord injury or trauma;
- IIEF-15 erectile function domain score less than 26;
- Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure);
- Men with PSA \> 20 ng/mL;
- History of ED, priapism and Peyronie disease;
- History of previous pelvic surgery, trauma or irradiation therapy;
- Currently have an active implantable device.
- Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions;
- Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation;
- Inability to understand and demonstrate device use instructions;
- Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications;
- Patient unwillingness to engage in sexual activity;
- Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function;
- Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months;
- Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study;
- Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06968494
Start Date
June 5 2025
End Date
April 1 2027
Last Update
November 7 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287