Status:
RECRUITING
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Lead Sponsor:
Elucent Medical
Conditions:
Tumors, Breast
Eligibility:
FEMALE
18+ years
Brief 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 informati...
Detailed Description
Objectives 1.) To collect data throughout clinical patient workflow for evaluation of. 1. localization with SmartClip(s) 2. negative margin on primary specimen 3. specimen assessment 4. length of op...
Eligibility Criteria
Inclusion
- 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
- Patients undergoing mastectomy for resection of the targeted lesion.
- Patient is localized with an alternative method.
- Patient that are pregnant.
Key Trial Info
Start Date :
August 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06572410
Start Date
August 7 2024
End Date
February 15 2026
Last Update
August 27 2024
Active Locations (1)
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1
Advent Winter Garden
Winter Garden, Florida, United States, 34787