Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
This study is not yet open for participant recruitment.
Verified September 2012 by UC Care, Ltd.
UC Care, Ltd.
Information provided by (Responsible Party):
UC Care, Ltd.
First received: September 12, 2012
Last updated: September 20, 2012
Last verified: September 2012
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample|
Resource links provided by NLM:
Further study details as provided by UC Care, Ltd.:
Primary Outcome Measures:
- percent of tissue loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 Outcome Measures:
- prostate cancer detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- processing time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692405
|Haemek madical center||Not yet recruiting|
|Afula, Israel, 18101|
|Contact: Michael Cohen, Dr. 04-6494306 email@example.com|
|Principal Investigator: Michael Cohen, MD|
Sponsors and Collaborators
UC Care, Ltd.