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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: biopsy sponge pad; Device: NaviGo Bx™

• Registration Number: NCT01692405
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Study Start: 2013-04-29
• Primary Completion: 2017-04-05
• Study Completion: 2017-04-24
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 436

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Download onto a biopsy sponge pad	biopsy sponge pad	Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
Dowloading the biopsy cores using NavigoBx system	NaviGo Bx™	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.

Primary Outcome Measures

Name	Time	Method
percent of tissue loss	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

Name	Time	Method
processing time	1 year
prostate cancer detection rate	1 year

Trial Locations

Locations (1)

Haemek madical center; 🇮🇱 Afula, Israel