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

Part of paid clinical trials in Winter Garden, Florida.

Sponsor
Elucent Medical
Study ID
NCT06572410
Status
Recruiting
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Conditions

  • Tumors, Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 7, 2024
Status verified
Aug 2024
Primary completion
Feb 1, 2026
Completion
Feb 15, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Cohort 1
    Patient has selected breast conservation therapy

Primary Outcome Measure

Margin Positivity [ Time Frame: Day of Surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advent Winter GardenWinter GardenFlorida34787
Jason A Boardman, MD
[email protected]
352-243-2622

Find similar trials in Winter Garden, FL

By research site
Advent Winter Garden· Winter Garden, FL

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