Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
1 other identifier
interventional
436
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Apr 2013
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedStudy Start
First participant enrolled
April 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2017
CompletedApril 19, 2019
September 1, 2012
3.9 years
September 12, 2012
April 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
prostate cancer detection rate
1 year
processing time
1 year
Study Arms (3)
Standard method
NO INTERVENTIONStandard method- shaking the biopsy needle into a formalin container.
Download onto a biopsy sponge pad
ACTIVE COMPARATORSamples will be downloaded by moving the needle notch on a biopsy sponge pad.
Dowloading the biopsy cores using NavigoBx system
EXPERIMENTALDownloading 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.
Interventions
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.
the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.
- Signed informed consent.
You may not qualify if:
- Patient's unwilling to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UC Care, Ltd.lead
Study Sites (1)
Haemek madical center
Afula, 18101, Israel
Related Publications (1)
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.
PMID: 22498214BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 25, 2012
Study Start
April 29, 2013
Primary Completion
April 5, 2017
Study Completion
April 24, 2017
Last Updated
April 19, 2019
Record last verified: 2012-09