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Tracking Information | |||||||||
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First Received Date † | April 23, 2007 | ||||||||
Last Updated Date | February 23, 2008 | ||||||||
Start Date † | April 2007 | ||||||||
Current Primary Outcome Measures † |
Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50% [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00465101 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization | ||||||||
Official Title † | A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH) | ||||||||
Brief Summary | Multi-center, prospective, one-arm study. A maximum of 150 subjects will be enrolled. Qualifying patients will receive treatment using a 120w laser for enlarged prostate. Symptoms will be evaluated prior to treatment, and then at 3 and 6 months, followed by a yearly visit out to 5 years post treatment for a total of 7 visits. The purpose of the study is to document advantages of GreenLight HPS in a long-term clinical trial. |
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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 200,000 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. Outcomes: Decrease in International Prostate Symptom (I-PSS), improvement in uroflow rate,and decrease in post-void residual score from baseline to 6 months. Rate of peri-operative and delayed hematuria will be captured and rate of absence of retrograde ejaculation and new onset of erectile dysfunction (ED). I-PSS, Quality of Life score from I-PSS, retrograde ejaculation and ED will be followed for 5 years. Length of time for patients to return to pre-treatment level of activity (excluding sex). Length of time for: hospital stay, catheterization, procedure, and lasing time. Number of fibers and total joules used per procedure will also be collected. Safety, defined by the incident rate of treatment-related complications that occur within 3 months post-treatment will be captured. |
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Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||||||
Condition † | Benign Prostatic Hyperplasia | ||||||||
Intervention † | Device: GreenLight HPS | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 150 | ||||||||
Estimated Completion Date | April 2013 | ||||||||
Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||||||
Ages | 45 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00465101 | ||||||||
Responsible Party | Dan Merz, Male Health, Prostate Program Manger, American Medical Systems, Inc. | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | American Medical Systems | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | American Medical Systems | ||||||||
Verification Date | February 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |