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. (see Contacts and Locations)
Verified September 2012 by UC Care, Ltd.
Sponsor:
Information provided by (Responsible Party):
UC Care, Ltd.
ClinicalTrials.gov Identifier:
NCT01692405
First received: September 12, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention
Prostate Cancer
Device: NaviGo Bx™
Procedure: biopsy sponge pad

Study Type: Interventional
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 ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
Publications:
Responsible Party: UC Care, Ltd.
ClinicalTrials.gov Identifier: NCT01692405     History of Changes
Other Study ID Numbers: 0086-12-EMC
Study First Received: September 12, 2012
Last Updated: September 20, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014