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

April 17, 2019 updated by: UC Care, Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Haemek madical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
prostate cancer detection rate
Time Frame: 1 year
1 year
processing time
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UC Care, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2013

Primary Completion (Actual)

April 5, 2017

Study Completion (Actual)

April 24, 2017

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0086-12-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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