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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Comphya Inc.
Study ID
NCT06968494
Status
Recruiting
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Conditions

  • Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

Sex
MALE
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 5, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Implanted group
    Participants in the implanted group will be implanted with the study device during ongoing prostatectomy surgery.
  • No Intervention: Control group
    Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device.

Primary Outcome Measure

Occurrence of adverse events [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Rana Harb
[email protected]
410-502-5500
Christian Pavlovich, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MD

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