Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06236802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2024-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ProVIDE II Bridging Study
Sponsor:
ProVerum Medical
Organization:
Study Overview
Official Title:
ProVIDE II Bridging Study for the ProVee System for BPH
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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 purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.
Detailed Description:
This is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to benign prostatic hyperplasia (BPH).
Study Oversight
Has Oversight DMC:
True
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?: