Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
- Conditions
- Tumors, Breast
- Registration Number
- NCT06572410
- Lead Sponsor
- Elucent Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria:<br><br> - Patient has image identifiable lesion.<br><br> - Patient has selected breast conservation therapy IE: lumpectomy +/-radiation<br> therapy, +/- chemotherapy +/- hormonal or targeted therapies. Neoadjuvant<br> chemotherapy is not an exclusion criterion.<br><br> - Patient will be undergoing target tissue localization with the SmartClip<br><br> - Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or<br> invasive breast cancer with EnVisio ® Navigation System.<br><br> - Patient must be age > or = 18 years.<br><br> - Patients unable to provide consent to surgery must have authorized representative<br> provide consent.<br><br>Exclusion Criteria:<br><br> - Patients undergoing mastectomy for resection of the targeted lesion.<br><br> - Patient is localized with an alternative method.<br><br> - Patient that are pregnant.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Margin Positivity
- Secondary Outcome Measures
Name Time Method