Evaluation of the SmartBx System for Breast Biopsy

Breast Cancer Clinical Trial

Official title:

Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808116
• Other study ID #: EMC-0124-18
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: August 2019
• 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:

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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Planned for breast biopsy procedure.

• Signed informed consent.

Exclusion Criteria:

o Patient's unwilling to participate.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula	North Region

Sponsors (1)

Lead Sponsor	Collaborator
UC Care, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biopsy core length	biopsy core length will be measured on the glass slide	1 month
Primary	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