Actively Recruiting
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Led by Elucent Medical · Updated on 2024-08-27
200
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Patients undergoing mastectomy for resection of the targeted lesion.
- Patient is localized with an alternative method.
- Patient that are pregnant.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Advent Winter Garden
Winter Garden, Florida, United States, 34787
Actively Recruiting
Research Team
J
Jason A Boardman, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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