Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
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|ClinicalTrials.gov Identifier: NCT01692405|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : April 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: NaviGo Bx™ Procedure: biopsy sponge pad||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample|
|Actual Study Start Date :||April 29, 2013|
|Actual Primary Completion Date :||April 5, 2017|
|Actual Study Completion Date :||April 24, 2017|
No Intervention: Standard method
Standard method- shaking the biopsy needle into a formalin container.
Active Comparator: Download onto a biopsy sponge pad
Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
Procedure: biopsy sponge pad
the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
Experimental: Dowloading the biopsy cores using NavigoBx system
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™
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.
- percent of tissue loss [ Time Frame: 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
- prostate cancer detection rate [ Time Frame: 1 year ]
- processing time [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692405
|Haemek madical center|
|Afula, Israel, 18101|