Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527371
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2007-09-06
Brief Title:
PVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Prospective Controlled Trial Comparing Photoselective Vaporization of the Prostate PVP-120W to Transurethral Resection of the Prostate TURP for the Treatment of Benign Hyperplasia of the Prostate BPH
Status:
COMPLETED
Status Verified Date:
2018-02
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:
PVP
Brief Summary:
In patients with an enlarged prostate benign prostatic hyperplasia is treatment using photoselective vaporization of the prostate PVP 120 Watt as effective and cost-effective as the standard treatment of transurethral resection of the prostate TURP A higher-power 120W laser system has recently been approved by Health Canada for the treatment of an enlarged prostate This system which uses laser energy to vaporize the prostate tissue will be compared with the current standard treatment of transurethral resection of the prostate This newer generation laser may offer more efficient removal of prostate tissue with fewer complications and may result in clinical and economic benefits compared to the standard treatment However there have been no studies comparing the 120W laser with the standard transurethral resection of the prostate This study will provide currently unavailable information for clinicians and decision makers
Detailed Description:
Following a review of treatments for benign prostatic hyperplasia BPH by the Medical Advisory Secretariat MAS of the Ontario Ministry of Health and Long-Term Care MOHLTC the Ontario Health Technology Advisory Committee OHTAC recommended that a registry study be conducted to establish longer term effectiveness and complication rates for PVP given the likelihood of increasing diffusion of this technology Since then the Medical Devices Bureau of the Therapeutic Products Directorate Health Canada has licensed in April 30 2007 a 120W-KTP laser system Greenlight HPS TM for sale in Canada As several new 120W systems will be operating in Ontario in the coming months there is an urgent need to evaluate the effectiveness cost-effectiveness and durability of 120W PVP compared to conventional TURP in the treatment of patients with BPH
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