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Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard method | No Intervention | Standard method- shaking the biopsy needle into a formalin container. | |
| Download onto a biopsy sponge pad | Active Comparator | Samples will be downloaded by moving the needle notch on a biopsy sponge pad. |
|
| Dowloading the biopsy cores using NavigoBx system | Experimental | Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaviGo Bx™ | Device | The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel. |
| Measure | Description | Time Frame |
|---|---|---|
| percent of tissue loss | percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| prostate cancer detection rate | 1 year | |
| processing time | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek madical center | Afula | 18101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22498214 | Background | Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| biopsy sponge pad | Procedure | the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |