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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorElucent Medical

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients undergoing mastectomy for resection of the targeted lesion.

Patient is localized with an alternative method.

Patient that are pregnant.

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • EnVisio Navigation System

    Device

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Cohort 11 intervention

Trial outcomes

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

Time frame
Day of Surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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