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| ID | Type | Description | Link |
|---|---|---|---|
| 0000022806 |
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The purpose of this study is to evaluate the performance of the GreenLightâ„¢ model 120 delivering higher average power to allow for more flexibility in the working distance of the delivery device with the same power density to tissue as that of the current GreenLight model. In addition this study will examine the Laserscope GDD (guided delivery device) that has been designed exclusively for use with the GreenLightâ„¢ model 120.
Benign Prostatic Hyperplasia (BPH) refers to a medical condition which occurs in aging men where the prostate gland is enlarged preventing the free flow of urine. This causes symptoms of frequent urination, constant feeling of urgency to go to the bathroom, and difficulty passing urine due to the obstruction caused by the enlarged gland. The incidence (number of new cases) of BPH increases from 40% among males between the ages of 50 and 60 years to 90% among males older than 80 years of age. Treatment of BPH is currently undergoing intense scrutiny due to the cost and morbidity (complications and disability due to the procedure) associated with the "gold standard" treatment, Transurethral Resection of the Prostate (TURP). The TURP procedure has established its place as a standard of care for BPH due to its exceptional clinical efficacy and established long-term durability. Despite the clinical prowess of TURP, there remain significant concerns regarding the relatively high incidence of postoperative morbidity and the significant economic burden on world healthcare systems. Laser vaporization prostatectomy, on the other hand, has developed into a relatively new technological advance that has been utilized with favorable outcomes for more than a decade.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GreenLight Model 120 Laser System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of the GreenLightÔ Model 120 Laser for the treatment (PVP) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of the Laserscope GDD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Te, MD | Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York-Presbyterian Hospital Cornell Univeristy | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| D052801 |
| Male Urogenital Diseases |