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Clinical Trial 20335

Cancer Type: Breast
Study Type: Device Feasibility
NCT#: NCT04604561

Phase: N/A
Principal Investigator: Lee, Marie

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Study Title

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.


Primary endpoints - To determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery. Secondary endpoints 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





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

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