Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.
- To determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery.
To compare the placement of the SmartClip on preoperative imaging to clip location on specimen radiography
- To evaluate placement and visibility of the clip by breast radiologists
- To evaluate intraoperative use of the device system by surgeons
- To evaluate surgical outcomes (margins, specimen size, length of operation) with use of the SmartClip
Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
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