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OpenTrials
Completed

NCT Number: NCT01692405

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Haemek madical center

Afula, 18101, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NaviGo Bx™

Device

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.

biopsy sponge pad

Procedure

the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.

Primary outcomes

  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 outcomes

  1. prostate cancer detection rate

    Time frame: 1 year

  2. processing time

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

UC Care, Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2012
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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