Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample

Study Overview
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Brief Summary
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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: Biopsy core length obtained (i.e. collecting all tissue fragments) Biopsy core yield (i.e. percent of tissue loss during the pathologic processing) Pathologist interpretability Processing time Prostate cancer detection.

Official Title
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Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: NaviGo Bx™
* Procedure: biopsy sponge pad


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard method<br>Standard method- shaking the biopsy needle into a formalin container. | |
| Active Comparator: Download onto a biopsy sponge pad<br>Samples will be downloaded by moving the needle notch on a biopsy sponge pad. | Procedure: biopsy sponge pad<br>* the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.<br>|
| Experimental: Dowloading the biopsy cores using NavigoBx system<br>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. | Device: NaviGo Bx™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate cancer detection rate |  | 1 year | 
| processing time |  | 1 year |