The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.
Study Type
OBSERVATIONAL
Enrollment
176
Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.
Birmingham Breast Care
Birmingham, Alabama, United States
Winship Cancer Institute-Emory St. Joseph's
Atlanta, Georgia, United States
Dalton Surgical Group
Dalton, Georgia, United States
Metro Surgical Associates Inc.
Lithonia, Georgia, United States
Lesion BIRADS score
Diagnostic imaging result
Time frame: Weeks prior to the Intact procedure
Imaging lesion size
Measured in mm
Time frame: Weeks prior to the Intact procedure
Lesion histology
Lesion biopsy results
Time frame: Weeks prior to the Intact procedure
Tissue margin (as reported from histology) rate
Procedure margin vs. margin size, measured in mm
Time frame: Weeks after the Intact procedure, up to approximately 12 weeks
Underestimation rate
Compared to maximum lesion size, measured in mm
Time frame: Weeks after the Intact procedure, up to approximately 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Holyoke Medical Center
Holyoke, Massachusetts, United States
Nashville Breast Center
Nashville, Tennessee, United States
The Breast Center at Chesapeake Regional Healthcare
Chesapeake, Virginia, United States