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

UC-Care Medical Systems

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: NaviGo Bx™; Procedure: biopsy sponge pad

Study type: Interventional

Funder types: Industry

Identifiers

NCT01692405

0086-12-EMC

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 3 patient groups

Standard method

No Intervention group

Description:

Standard method- shaking the biopsy needle into a formalin container.

Download onto a biopsy sponge pad

Active Comparator group

Description:

Samples will be downloaded by moving the needle notch on a biopsy sponge pad.

Treatment:

Procedure: biopsy sponge pad

Dowloading the biopsy cores using NavigoBx system

Experimental group

Description:

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.

Treatment:

Device: NaviGo Bx™