Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02021032
Status:
UNKNOWN
Last Update Posted:
2015-09-24
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Sponsor:
Medifocus, Inc.
Organization:
Study Overview
Official Title:
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
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 primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: