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NCT06968494 · ClinicalTrials.gov registry record · NA
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
A NA study of Erectile Dysfunction Following Radical Prostatectomy, sponsored by Comphya.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06968494: Recruiting NA study of Erectile Dysfunction Following Radical Prostatectomy, sponsored by Comphya.
NCT06968494 is a NA study of Erectile Dysfunction Following Radical Prostatectomy that is actively recruiting participants, run by Comphya. The registered enrollment target is 20 participants, below the 211-participant average among 4 other Erectile Dysfunction Following Radical Prostatectomy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06968494, a NA study of Erectile Dysfunction Following Radical Prostatectomy, is actively recruiting participants, sponsored by Comphya.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Adverse events will be systematically reported.
Conditions Studied
Interventions
- DEVICE Activation of pro-erectile nerves within the pelvic plexus
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2027-04 |
| Phase | NA |
What NCT06968494 shows while recruiting
NCT06968494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 211-participant average among 4 other Erectile Dysfunction Following Radical Prostatectomy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Erectile Dysfunction Following Radical Prostatectomy appearing as the primary indexed condition, and to 1 intervention - of which Activation of pro-erectile nerves within the pelvic plexus is the first listed.
NCT06968494 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06968494 about?
NCT06968494 is a clinical study titled "Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction". 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 devic...
What is the current status of trial NCT06968494?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-06-05. Estimated completion is 2027-04.
What conditions does trial NCT06968494 study?
This clinical trial studies the following conditions: Erectile Dysfunction Following Radical Prostatectomy.
What interventions are being tested in trial NCT06968494?
The interventions under investigation include: Activation of pro-erectile nerves within the pelvic plexus (DEVICE).
Who is sponsoring clinical trial NCT06968494?
This trial is sponsored by Comphya, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06968494 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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