Evaluation of the SmartBx System for Breast Biopsy

Study Overview
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Brief Summary
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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)

Detailed Description
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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: On the needle notch [A]. 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)

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: SmartBx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Planned for breast biopsy procedure. Signed informed consent. Exclusion Criteria: o Patient's unwilling to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartBx biopsy collection<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast biopsy