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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 : Unknown
Verified September 2012 by UC Care, Ltd..
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
UC Care, Ltd.

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: NaviGo Bx™ Procedure: biopsy sponge pad Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Study Start Date : October 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. prostate cancer detection rate [ Time Frame: 1 year ]
  2. processing time [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Israel
Haemek madical center Not yet recruiting
Afula, Israel, 18101
Contact: Michael Cohen, Dr.    04-6494306    dr.m.cohen@gmail.com   
Principal Investigator: Michael Cohen, MD         
Sponsors and Collaborators
UC Care, Ltd.

Additional Information:
Publications:
Responsible Party: UC Care, Ltd.
ClinicalTrials.gov Identifier: NCT01692405     History of Changes
Other Study ID Numbers: 0086-12-EMC
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012