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Trial Title:
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
NCT ID:
NCT06572410
Condition:
Tumors, Breast
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
EnVisio Navigation System
Description:
Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive
breast cancer with EnVisio Navigation System.
Arm group label:
Cohort 1
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
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 operation
The EnVisio® Navigation System was cleared as a Class II device by the FDA under 510(k)
number K183400. The SmartClip® Soft Tissue Marker was cleared by the FDA under 510(k)
number K180640.
Principal Investigator will receive monthly EnVisio system data from Company
representative on the EnVisio system data collection for procedural cross reference
resulting in.
- Date
- Time of SmartClip(s) auto detection
- Color and Number of SmartClip(s)
- Total time of EnVisio Guidance
- Specimen Assessment recordings of SmartClip to specimen edge as recorded by
electrocautery tip on identified margin
Medial/Lateral/Superior/Inferior/Anterior/Posterior)
Data will be collected from procedures performed including all imaging, clinical and
pathologic outcomes. Pre and Post procedure data including number of individual lesions,
localization of mass and number of SmartClips used. Patients planning surgical excision
of an imaging identifiable in-breast will be offered entry into this study; the
AdventHealth Winter Garden location will provide standard informed consent form for the
purposes of this study. The projected accrual for this study is 200 patients in total.
Criteria for eligibility:
Study pop:
Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive
breast cancer with EnVisio ® Navigation System
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Patients undergoing mastectomy for resection of the targeted lesion.
- Patient is localized with an alternative method.
- Patient that are pregnant.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Advent Winter Garden
Address:
City:
Winter Garden
Zip:
34787
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jason A Boardman, MD
Phone:
352-243-2622
Email:
jaboardmanmd@hotmail.com
Start date:
August 7, 2024
Completion date:
February 15, 2026
Lead sponsor:
Agency:
Elucent Medical
Agency class:
Industry
Source:
Elucent Medical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572410
