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| Name | Class |
|---|---|
| American Medical Systems | INDUSTRY |
| Richard Wolf Medical Instruments Corporation (RWMIC) | UNKNOWN |
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This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Greenlight XPS Laser | Active Comparator | Greenlight XPS Laser of the prostate |
|
| BiVAP Saline Vaporization | Active Comparator | BiVAP Saline Vaporization of the prostate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Greenlight XPS Laser | Device | Treatment of BPH with Greenlight XPS laser |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in American Urological Association Symptom Score | The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms | Baseline and 12 months |
| Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax) | maximum urinary flow rate was measures using uroflow device | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Months in Post Void Residual Volume | post void residual was measured using a bladder scan device | baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooklyn Urology Research Group | Brooklyn | New York | 11215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Greenlight XPS Laser | Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser |
| FG001 | BiVAP Saline Vaporization | BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BiVAP Saline Vaporization of the prostate |
| Device |
treatment of BPH with BiVAP Saline Vaporization |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Greenlight XPS Laser | Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser |
| BG001 | BiVAP Saline Vaporization | BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in American Urological Association Symptom Score | The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms | All people who completed the study and had data available | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax) | maximum urinary flow rate was measures using uroflow device | all participants who completed the study and have available data | Posted | Mean | Standard Deviation | ml/sec | baseline and 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Months in Post Void Residual Volume | post void residual was measured using a bladder scan device | all participants who completed the study and have available data | Posted | Mean | Standard Deviation | ml | baseline and 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Greenlight XPS Laser | Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser | 0 | 31 | 0 | 31 | 2 | 31 |
| EG001 | BiVAP Saline Vaporization | BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization | 0 | 35 | 0 | 35 | 4 | 35 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urethral stricture | Renal and urinary disorders | Non-systematic Assessment |
| ||
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ivan Grunberger, M.D. Medical Director | Brooklyn Urology Research Group | 718-230-7788 | ivg9002@nyp.org |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Male |
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