In Vivo Smart Biopsy Device Protocol In Radiology

In Vivo Smart Biopsy Device Protocol In Radiology

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

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.

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