About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients undergoing mastectomy for resection of the targeted lesion.
Patient is localized with an alternative method.
Patient that are pregnant.
Trial population
Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System
Trial design
Other
Prospective
Treatments tested in this trial
EnVisio Navigation System
DevicePatient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio Navigation System.
Treatment groups
Trial outcomes
Primary outcomes
Margin Positivity
Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery. Definitive gross pathology results on final margin
Sponsors and contacts
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