Viewing Study NCT00199550


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Study NCT ID: NCT00199550
Status: COMPLETED
Last Update Posted: 2008-07-29
First Post: 2005-09-13
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:

Study Overview

Official Title: A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Status: COMPLETED
Status Verified Date: 2008-07
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: This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.
Detailed Description: The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a \< 24 hour post-operative hospital stay in \> 50% of patients undergoing this procedure.

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?: