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

Recruiting

• Conditions: Tumors, Breast
• Interventions: Device: EnVisio Navigation System

• Registration Number: NCT06572410
• Lead Sponsor: Elucent Medical

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 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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-07
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	EnVisio Navigation System	Patient has selected breast conservation therapy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Advent Winter Garden; 🇺🇸 Winter Garden, Florida, United States