Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Recruiting now
Conditions studied: Tumors, Breast
In brief
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
Key facts
- Study ID
- NCT06572410
- Run by
- Elucent Medical
- People needed
- 200
- Starts
- 2024-08-07
- Expected to finish
- 2026-02-15
- Last updated by the study team
- 2024-08-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- Patients undergoing mastectomy for resection of the targeted lesion.
- Patient is localized with an alternative method.
- Patient that are pregnant.
Where it is running
- Advent Winter Garden — Winter Garden, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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