Observational Study of EnVisio Navigation System for Breast Tumor Removal
This study is looking at how well a new tool, the EnVisio Navigation System, helps surgeons remove breast tumors. It's for women aged 18 and older who are having breast-conserving surgery (lumpectomy) for breast cancer or DCIS (Ductal Carcinoma In Situ, a non-invasive form of breast cancer). You must have a tumor that can be seen on imaging and be having a SmartClip (a small marker) placed in your breast. The study aims to see if using the EnVisio system helps surgeons remove the entire tumor in one go, leaving no cancer cells behind at the edges of the removed tissue (negative margin). This is an observational study, meaning researchers will collect information during your standard surgery. The study plans to include 200 patients.
- Study design
- This is an observational study involving 200 women. Researchers will collect data during your standard breast-conserving surgery.
- What's involved
- You will undergo breast-conserving surgery with the EnVisio Navigation System and SmartClip localization as part of your standard treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, margin positivity, is measured on the day of surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Margin PositivityDay of Surgery
Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery. Definitive gross pathology results on final margin