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)

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: SmartBx

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • North Region
    • Afula, North Region, Israel, 1834111
      • Haemek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

o Patient's unwilling to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SmartBx biopsy collection; 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

Device: SmartBx; he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation. The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following: To preserve sample unity, including core fragments in their original location along the needle notch.; Avoid sample damaging during sample removal from the needle and the following pathology process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biopsy core length	biopsy core length will be measured on the glass slide	1 month
biopsy core yield	biopsy core length will be measured on the needle and on the glass slide and for each core the length on the slide will be computed in reference to the length on the needle	1 month

Collaborators and Investigators

• Sponsor: UC Care, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: breast biopsy
• Other Study ID Numbers: EMC-0124-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No