Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06968494
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Sponsor:
Comphya Inc.
Organization:
Study Overview
Official Title:
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: