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| Name | Class |
|---|---|
| Richard Wolf Medical Instruments Corporation (RWMIC) | UNKNOWN |
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To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity.
A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure.
Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumenis VersaCut Morcellator | Other | Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation |
|
| Wolf Piranha Morcellator | Other | Wolf Piranha Morcellator will be utilized for prostate tissue morcellation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumenis VersaCut Morcellator | Device |
| ||
| Wolf Piranha Morcellator |
| Measure | Description | Time Frame |
|---|---|---|
| Morcellation Rate | Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate." | Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth |
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Inclusion Criteria:
Exclusion Criteria:
• Inability to give informed consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Physicians Urology | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumenis VersaCut Morcellator | Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation Lumenis VersaCut Morcellator |
| FG001 | Wolf Piranha Morcellator | Wolf Piranha Morcellator will be utilized for prostate tissue morcellation Wolf Piranha Morcellator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumenis VersaCut Morcellator | Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation Lumenis VersaCut Morcellator |
| BG001 | Wolf Piranha Morcellator | Wolf Piranha Morcellator will be utilized for prostate tissue morcellation Wolf Piranha Morcellator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Morcellation Rate | Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate." | Posted | Mean | Full Range | grams/minute | Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth |
|
adverse event data collected intraoperatively through hospital discharge, which is typically less than 24 hours total
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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 | Wolf Piranha Morcellator | 0 | 37 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Lingeman, MD | IU Health Physicians Urology | 317-962-3700 |
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| Device |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Lumenis VersaCut Morcellator | 0 | 37 | 0 | 37 | 0 | 37 |
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