Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

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.

Inclusion Criteria:

• 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.
• Participants must be age > or = 18 years.

Exclusion Criteria:

• Participants with sonographically or mammographically occult target lesions
• Participants with greater than 35cm chest to bust depth
• Participants undergoing mastectomy for resection of the targeted lesion
• Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines
• Patients requiring use of more than 3 SmartClips to localize targets