Erectile Dysfunction Following Radical ProstatectomyNCT06968494
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
A study testing Activation of pro-erectile nerves within the pelvic plexus in people with Erectile Dysfunction Following Radical Prostatectomy, run by Comphya Inc. at 1 site in United States.
Trial 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: Is the device safe? Does the device works well? Are the participants satisfied with the device? Participants will be… Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Activation of pro-erectile nerves within the pelvic plexus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Rana Harb, 410-502-5500, rharb1@jhmi.edu
Christian Pavlovich, MD
About this study
Official title: 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:
Read more
- 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.
- Being tested
- Activation of pro-erectile nerves within the pelvic plexus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation of pro-erectile nerves within the pelvic plexusDevice
The study device is an active implantable device. The device activates the pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function.
| Study group | Role | What they receive |
|---|---|---|
| Implanted group | Experimental | Participants in the implanted group will be implanted with the study device during ongoing prostatectomy surgery. Receives: Device: Activation of pro-erectile nerves within the pelvic plexus |
| Control group | No intervention | Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Adverse events will be systematically reported.
Measured: 6 months
Occurrence of surgical complications
Surgical complications will be ranked according to the Clavien-Dindo classification
Measured: 6 months
Occurrence of device deficiencies
Device deficiencies will be systematically reported and recorded.
Measured: 6 months
Pain assessment
Participants will be asked to rate pain on a visual analog scale (from 0 to 10)
Measured: 6 months
Secondary outcomes (4)
Device Effectiveness
Device effectiveness will be assessed by asking participants to complete validated questionnaires.
Measured: 6 months
Erectile function rehabilitation
Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of rehabilitation of natural erectile function.
Measured: 6 months
Duration of Surgical Implantation Procedure
Time (in minutes) from initial implant placement to final suture of the implant.
Measured: During surgical procedure
Ease of Implantation Steps
Surgeon-reported rating of the ease of each implantation step using a standardized ordinal scale.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comphya Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Pavlovich, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968494
- Sponsor's protocol ID
- CP-1.103
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06968494
- Acronym / sponsor ID
- CP-1.103
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Comphya Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implanted group | Experimental | Device: Activation of pro-erectile nerves within the pelvic plexusParticipants in the implanted group will be implanted with the study device during ongoing prostatectomy surgery. |
| Control group | No intervention | –Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activation of pro-erectile nerves within the pelvic plexusThe study device is an active implantable device. The device activates the pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function. | Device | Implanted group |
Primary outcome
Occurrence of adverse events
Time frame: 6 months
Adverse events will be systematically reported.
Occurrence of surgical complications
Time frame: 6 months
Surgical complications will be ranked according to the Clavien-Dindo classification
Occurrence of device deficiencies
Time frame: 6 months
Device deficiencies will be systematically reported and recorded.
Pain assessment
Time frame: 6 months
Participants will be asked to rate pain on a visual analog scale (from 0 to 10)
4 secondary outcomes
Device Effectiveness
Time frame: 6 months
Erectile function rehabilitation
Time frame: 6 months
Duration of Surgical Implantation Procedure
Time frame: During surgical procedure
Ease of Implantation Steps
Time frame: During surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Pavlovich, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activation of pro-erectile nerves within the pelvic plexus in people with Erectile Dysfunction Following Radical Prostatectomy, run by Comphya Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana Harb (410-502-5500, rharb1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.