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Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01692405
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : April 19, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 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
Actual Study Start Date : April 29, 2013
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 24, 2017

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT01692405

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Haemek madical center
Afula, Israel, 18101
Sponsors and Collaborators
UC Care, Ltd.

Additional Information:
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Responsible Party: UC Care, Ltd. Identifier: NCT01692405    
Other Study ID Numbers: 0086-12-EMC
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: September 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases