Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
Study NCT ID:
NCT03767595
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2018-12-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ProACT Post-Approval Study
Sponsor:
Uromedica
Organization:
Study Overview
Official Title:
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
Status:
RECRUITING
Status Verified Date:
2024-11
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 ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
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?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: