Recruiting

EnVisio Spatial Intelligence

Sponsor:

Elucent Medical

Code:

NCT06572410

Conditions

Tumors, Breast

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EnVisio Navigation System

Study Details

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

Study ID

NCT06572410

Start date

Aug 7, 2024

Status verified date

Aug, 2024

Completion date

Feb 15, 2026

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Patient has selected breast conservation therapy

Interventions

EnVisio Navigation System

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

Primary outcome measure

  • Margin Positivity [ Time Frame: Day of Surgery ]

Central Contacts and Locations

Central contacts

Jason A Boardman, MD

352-243-2622jaboardmanmd@hotmail.com

Locations

Advent Winter Garden

Recruiting

Winter Garden, Florida, United States, 34787

Contacts

Jason A Boardman, MD

352-243-2622jaboardmanmd@hotmail.com

More Information

Sponsor

Elucent Medical

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elucent Medical on 2024-08-27.