Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037141
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2002-05-15
Brief Title:
SafetyTolerability Study of Alcohol Injection for Treatment of BPH Enlarged Prostate
Sponsor:
American Medical Systems
Organization:
American Medical Systems
Study Overview
Official Title:
Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH Enlarged Prostate
Status:
COMPLETED
Status Verified Date:
2004-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multi-center prospective randomized dosing and safety research study A maximum of 150 men will be enrolled in the study Qualifying patients will receive one of three possible doses of the study drug Symptoms will be evaluated before treatment and then 1-week 1-month 3-months and 6-months following treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None