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

NCT01692405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2019-04-19

No results posted yet for this study

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.

Conditions

Interventions

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.

PROCEDURE

biopsy sponge pad

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

Sponsors & Collaborators

  • UC Care, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-29
Primary Completion
2017-04-05
Completion
2017-04-24

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01692405 on ClinicalTrials.gov