RecruitingNCT06572410

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

Sponsor

Elucent Medical

Enrollment

200 participants

Start Date

Aug 7, 2024

Study Type

OBSERVATIONAL

Conditions

Tumors, Breast

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a navigation system called EnVisio that helps surgeons precisely locate and remove breast tissue during a lumpectomy (breast-conserving surgery). It uses a small implanted clip and imaging technology to guide the surgeon. **You may be eligible if...** - You have a breast lesion that can be seen on imaging - You have chosen breast-conserving surgery (lumpectomy) for DCIS or invasive breast cancer - You will have a SmartClip placed to mark the tissue before surgery - You are 18 years of age or older **You may NOT be eligible if...** - You are having a full mastectomy (complete breast removal) - Your tissue is being located using a different method (not the SmartClip) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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