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

NCT06968494 | Recruiting FDA Device

• 1 other identifier: CP-1.103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• 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

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (4)

• Occurrence of adverse events

  Adverse events will be systematically reported.

  6 months

• Occurrence of surgical complications

  Surgical complications will be ranked according to the Clavien-Dindo classification

  6 months

• Occurrence of device deficiencies

  Device deficiencies will be systematically reported and recorded.

  6 months

• Pain assessment

  Participants will be asked to rate pain on a visual analog scale (from 0 to 10)

  6 months

Secondary Outcomes (4)

• Device Effectiveness

  6 months

• Erectile function rehabilitation

  6 months

• Duration of Surgical Implantation Procedure

  During surgical procedure

• Ease of Implantation Steps

  During surgical procedure

Study Arms (2)

Implanted group

EXPERIMENTAL

Participants in the implanted group will be implanted with the study device during ongoing prostatectomy surgery.

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.

Interventions

Activation of pro-erectile nerves within the pelvic plexus DEVICE

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.

Implanted group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Gender Eligibility Details: Gender eligibility: male. Not based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Comphya Inc.: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Study Officials

• Christian Pavlovich, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Harb

CONTACT

410-502-5500; rharb1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 13, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)