Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision

Objectives

1.) To collect data throughout clinical patient workflow for evaluation of.

• localization with SmartClip(s)
• negative margin on primary specimen
• specimen assessment
• length of operation

The EnVisio® Navigation System was cleared as a Class II device by the FDA under 510(k) number K183400. The SmartClip® Soft Tissue Marker was cleared by the FDA under 510(k) number K180640.

Principal Investigator will receive monthly EnVisio system data from Company representative on the EnVisio system data collection for procedural cross reference resulting in.

• Date
• Time of SmartClip(s) auto detection
• Color and Number of SmartClip(s)
• Total time of EnVisio Guidance
• Specimen Assessment recordings of SmartClip to specimen edge as recorded by electrocautery tip on identified margin Medial/Lateral/Superior/Inferior/Anterior/Posterior)

Data will be collected from procedures performed including all imaging, clinical and pathologic outcomes. Pre and Post procedure data including number of individual lesions, localization of mass and number of SmartClips used. Patients planning surgical excision of an imaging identifiable in-breast will be offered entry into this study; the AdventHealth Winter Garden location will provide standard informed consent form for the purposes of this study. The projected accrual for this study is 200 patients in total.

Inclusion criteria

• Patient has image identifiable lesion.
• Patient has selected breast conservation therapy IE: lumpectomy +/-radiation therapy, +/- chemotherapy +/- hormonal or targeted therapies. Neoadjuvant chemotherapy is not an exclusion criterion.
• Patient will be undergoing target tissue localization with the SmartClip
• Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System.
• Patient must be age > or = 18 years.
• Patients unable to provide consent to surgery must have authorized representative provide consent.

Exclusion criteria

• Patients undergoing mastectomy for resection of the targeted lesion.
• Patient is localized with an alternative method.
• Patient that are pregnant.