Back to resultsSemi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NaviGo Bx™
biopsy sponge pad
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- Haemek madical center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Standard method
Download onto a biopsy sponge pad
Dowloading the biopsy cores using NavigoBx system
Arm Description
Standard method- shaking the biopsy needle into a formalin container.
Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
prostate cancer detection rate
processing time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01692405
Brief Title
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Official Title
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 29, 2013 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UC Care, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard method
Arm Type
No Intervention
Arm Description
Standard method- shaking the biopsy needle into a formalin container.
Arm Title
Download onto a biopsy sponge pad
Arm Type
Active Comparator
Arm Description
Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
Arm Title
Dowloading the biopsy cores using NavigoBx system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NaviGo Bx™
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
biopsy sponge pad
Intervention Description
the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
Primary Outcome Measure Information:
Title
percent of tissue loss
Description
percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide
Time Frame
1 year
Secondary Outcome Measure Information:
Title
prostate cancer detection rate
Time Frame
1 year
Title
processing time
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Haemek madical center
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
22498214
Citation
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.
Results Reference
background
Links:
URL
http://hospitals.clalit.co.il/hospitals/emek/he-il/Pages/homepage.aspx
Description
Haemek medical center home page
Learn more about this trial
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
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