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

Summary

Observational study. The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen. Prospective Patient Study: 200 consecutive patients

Eligibility

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.

Conditions3

Locations1 site

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