Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465101
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2007-04-23
Brief Title:
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
Sponsor:
American Medical Systems
Organization:
American Medical Systems
Study Overview
Official Title:
A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia BPH
Status:
COMPLETED
Status Verified Date:
2012-06
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:
PVP
Brief Summary:
To gain clinical experience with the GreenLight HPS System a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms
Detailed Description:
Enlarged prostate or Benign Prostatic Hyperplasia BPH is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms LUTS such as having to urinate very often a sudden strong feeling of having to urinate having to get up at night to urinate decreased and intermittent force of stream and the feeling of incomplete bladder emptying These symptoms affect quality of life by interfering with normal daily activities and sleep patterns When surgery is the best treatment option for the patient the most common technique is a transurethral resection of the prostate TURP TURP involves removing the some of the extra tissue of the prostate gland Even though TURP is a good treatment there are concerns about the frequency of complications following treatment as well as the significant costs to patients doctors and insurance providers
Photoselective vaporization of the prostate PVP is a relatively new technology that has similar benefits with fewer side effects than TURP PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area This technology has been used for more than a decade with over 200000 procedures performed worldwide
The focus of this study is to 1 document the long-term advantages of GreenLight HPS 120w and 2 to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time may be done in an out-patient setting in healthy patients allows for shorter catheterization time may result in a rapid urinary flow rate with minimal side effects and may allow a quick return to normal activities This device has been approved by the United States Food and Drug Administration FDA for treatment of obstructive BPH
Photoselective vaporization of the prostate PVP is a relatively new technology that has similar benefits with fewer side effects than TURP PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area This technology has been used for more than a decade with over 200000 procedures performed worldwide
The focus of this study is to 1 document the long-term advantages of GreenLight HPS 120w and 2 to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time may be done in an out-patient setting in healthy patients allows for shorter catheterization time may result in a rapid urinary flow rate with minimal side effects and may allow a quick return to normal activities This device has been approved by the United States Food and Drug Administration FDA for treatment of obstructive 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