Evaluation of the SmartBx System for Breast Biopsy

UC-Care Medical Systems

Status: Completed

Conditions: Breast Cancer

Treatments: Device: SmartBx

Study type: Interventional

Funder types: Industry

Identifiers

NCT03808116

EMC-0124-18

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:

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)

Full description

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)

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

o Patient's unwilling to participate.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SmartBx biopsy collection

Experimental group

Description:

* 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

Treatment:

Device: SmartBx