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

Launched by ELUCENT MEDICAL · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the EnVisio Surgical Navigation System, which helps doctors locate and remove soft tissue tumors in the breast during surgery. The goal is to see how well this system works in guiding surgeons to ensure they remove all of the tumor while leaving as much healthy tissue as possible. Researchers will gather information from 200 women who are having surgery for breast cancer to understand how effective this technology is in achieving good surgical outcomes.

To participate in this study, women must be at least 18 years old and have a specific type of breast cancer that can be identified through imaging. They should be planning to have a breast-conserving surgery, like a lumpectomy, which allows them to keep most of their breast tissue. Participants will also have a special device called SmartClip placed to help guide the surgery. It's important to note that women who are pregnant or are having a mastectomy (complete removal of the breast) will not be eligible for this study. Those who join can expect to receive close monitoring during their surgery and contribute to valuable research that could improve future cancer treatments.

Gender

FEMALE

Eligibility criteria

• 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.