At a glance
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Clinical Evaluation of CEM-guided Biopsy
In Brief
An observational study evaluating CEM-guided biopsy for Contrast Enhanced Mammography-guided Biopsy. Completed, enrolled 66 participants across 1 site.
Detailed Summary
CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use. This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.
Study Details
Timeline
Interventions
The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination (with no clear ultrasound or mammography correlation) and considered eligible for this procedure as per standard of care. Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena Bright ® CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.