Prostate Cancer
Conditions
Brief summary
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of: 1. Biopsy core length obtained (i.e. collecting all tissue fragments) 2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing) 3. Pathologist interpretability 4. Processing time 5. Prostate cancer detection.
Interventions
DEVICENaviGo Bx™
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.
PROCEDUREbiopsy sponge pad
the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
Sponsors
UC Care, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure. * Signed informed consent.
Exclusion criteria
* Patient's unwilling to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percent of tissue loss | 1 year | percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide |
Secondary
| Measure | Time frame |
|---|---|
| prostate cancer detection rate | 1 year |
| processing time | 1 year |
Countries
Israel
Outcome results
None listed