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

NCT06572410 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-08-27

No results posted yet for this study

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

Interventions

DEVICE

EnVisio Navigation System

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

Sponsors & Collaborators

  • Elucent Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2026-02-01
Completion
2026-02-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572410 on ClinicalTrials.gov