Evaluation of the SmartBx System for Breast Biopsy

Evaluation of the SmartBx System for Breast Biopsy Download 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:

3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Examination procedure:

• Biopsy cores will be collected from the breast during US guided biopsy procedure.

• The number of cores taken will be decided per the physician discretion according to the clinical demand.

• Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx cassette holds two biopsies together, two consecutive cores will be collected using the SmartBx.

• samples will be photographed for measurements in 2 steps during the process:

  1. On the needle notch [A].
  2. On the glass slide [B].

• Standard tissue fixation, processing of the samples in paraffin will be performed unchanged per the pathology laboratory protocols.

• Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx mold and tamper.

• Standard staining and histology analysis will be preformed to the sectioned samples, unchanged per the pathology protocols.

  • Analysis will be preformed to the histological results, and a comparison between the standard procedures samples to the SmartBx samples will be performed in terms of -

• Biopsy core length obtained (i.e. collecting all tissue fragments)

• Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Inclusion Criteria:

• Age 18 years or older
• Planned for breast biopsy procedure.
• Signed informed consent.

Exclusion Criteria:

o Patient's unwilling to participate.