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

NCT06572410 | Recruiting FDA Device

• 1 other identifier: 20242689
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Tumors, Breast

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cohort 1

Patient has selected breast conservation therapy

Device: EnVisio Navigation System

Interventions

EnVisio Navigation System DEVICE

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient has image identifiable lesion.
• 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.

Sponsors & Collaborators

• Elucent Medical: lead

Study Sites (1)

Advent Winter Garden

Winter Garden, Florida, 34787, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jason A Boardman, MD

CONTACT

352-243-2622; jaboardmanmd@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 27, 2024
• Study Start: August 7, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 15, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)