Observational Study of EnVisio Navigation System for Breast Tumor Removal

This study is looking at how well a new tool, the EnVisio Navigation System, helps surgeons remove breast tumors. It's for women aged 18 and older who are having breast-conserving surgery (lumpectomy) for breast cancer or DCIS (Ductal Carcinoma In Situ, a non-invasive form of breast cancer). You must have a tumor that can be seen on imaging and be having a SmartClip (a small marker) placed in your breast. The study aims to see if using the EnVisio system helps surgeons remove the entire tumor in one go, leaving no cancer cells behind at the edges of the removed tissue (negative margin). This is an observational study, meaning researchers will collect information during your standard surgery. The study plans to include 200 patients.

Study design
This is an observational study involving 200 women. Researchers will collect data during your standard breast-conserving surgery.
What's involved
You will undergo breast-conserving surgery with the EnVisio Navigation System and SmartClip localization as part of your standard treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, margin positivity, is measured on the day of surgery.

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NCT06572410

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

UNKNOWN
Not specifiedAges 18+Observational
Elucent Medical
~200 participants
Updated 2024-08-27 on ClinicalTrials.gov
What's tested:EnVisio Navigation System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Margin Positivity
Measured over Day of Surgery
Tumors, Breast
1 sites across 1 states
Florida1

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Eligibility criteria

Inclusion

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

Patients undergoing mastectomy for resection of the targeted lesion.
Patient is localized with an alternative method.
Patient that are pregnant.
  • Margin PositivityDay of Surgery

    Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery. Definitive gross pathology results on final margin