In Vivo Smart Biopsy Device Protocol In Radiology

Study Overview
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Brief Summary
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This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.

Detailed Description
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This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast. The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.

Official Title
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In Vivo Smart Biopsy Device Protocol In Radiology

Conditions
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Breast Cancer, Image Guided Biopsy

Intervention / Treatment
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* Device: Smart Biopsy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 18 years of age Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast Signed Informed Consent Form Exclusion Criteria: Concurrent infectious disease Pregnancy or breastfeeding Participating in any other investigational study for either drug or device which can influence collection of valid data under this study Implanted devices / Implants in the operated breast

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>The radiologist will perform a routine ultrasonic guided biopsy procedure using the Smart Biopsy Device, with the device readings not visible (i.e. the radiologist will be blinded to device readings) | Device: Smart Biopsy Device<br>* The radiologist will perform a routine ultrasonic guided biopsy procedure using the smart biopsy system, with the device readings not visible (i.e. the radiologist will be blinded to device readings)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs) | AEs will be documented during the biopsy procedure and SAEs will be followed up to 3 weeks after the biopsy procedure. Rates of adverse events such as bleeding, hematoma, infection and pain will be compared to adverse events for similar procedures published in the literature and anticipated in the product risk analysis. | The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure | 
| Correlation between pathology results and device readings | Correlation between pathology results and device readings | 2-3 weeks following biopsy procedure | 
| Ergonomic Assessment of the Smart Biopsy Device | A questionnaire will be completed by the radiologist and applicable radiology lab staff to assess the ease of device assembly and handling properties. Each of the eight questions will use the same four point rating scale. At the end of the study the average and standard deviation will be calculated for each of the questions. | At the day of the biopsy procedure |