Study of EnVisio Navigation System for Locating and Surgically Removing Breast Tumors Using SmartClip Markers During Breast Conserving Surgery

What this Trial Is About

This research aims to evaluate the use of real-time surgical navigation technology to locate and remove soft tissue tumors, specifically in the breast. The study focuses on assessing the efficiency and effectiveness of the EnVisio Surgical Navigation System in guiding surgery to achieve negative margins on the initial tissue specimen. The study plans to enroll 200 female patients undergoing breast conservation therapy for ductal carcinoma in situ DCIS or invasive breast cancer. Participants will undergo breast-conserving surgery using the EnVisio Navigation System combined with SmartClip tissue markers. The system provides intraoperative guidance by detecting SmartClips placed near the tumor, helping surgeons precisely locate and remove the tumor tissue. Data collected includes timing of SmartClip detection, duration of navigation guidance, and specimen margin assessments recorded during surgery. Throughout the study, researchers will collect clinical data, imaging, and pathology results related to tumor localization and surgical outcomes. They will track the number of lesions, number of SmartClips used, and measure margin positivity on the day of surgery. Participants will be monitored as part of their usual clinical care, with data collection integrated into their surgical workflow. The study began in August 2024 and expects to complete by February 2026.

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