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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692405
• Other study ID #: 0086-12-EMC
• Status: Completed
• Phase: N/A
• Start date: April 29, 2013
• Est. completion date: April 24, 2017

Study information

• Verified date: September 2012
• Source: UC Care, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: April 24, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
Israel	Haemek madical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
UC Care, Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Öbek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent of tissue loss	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	prostate cancer detection rate		1 year
Secondary	processing time		1 year

External Links

•   Haemek medical center home page