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

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

Study Overview

• Status: Recruiting
• Conditions: Tumors, Breast
• Intervention / Treatment: Device: EnVisio Navigation System

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jason A Boardman, MD; Phone Number: 352-243-2622; Email: jaboardmanmd@hotmail.com

Study Locations

• United States
  • Florida
    • Winter Garden, Florida, United States, 34787
      • Recruiting
      • Advent Winter Garden
      • Contact: Jason A Boardman, MD; Phone Number: 352-243-2622; Email: jaboardmanmd@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Patient has selected breast conservation therapy	Device: EnVisio Navigation System; Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio Navigation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Margin Positivity	Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery. Definitive gross pathology results on final margin	Day of Surgery

Collaborators and Investigators

• Sponsor: Elucent Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20242689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No