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Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

NCT04604561 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-01

No results posted yet for this study

Summary

This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.

Conditions

Interventions

DEVICE

EnVisio SmartClip

The Envisio SmartClip is an FDA-cleared (approved) device for localization of in-breast lesions. While using The EnVisio™ Navigation System, the system will detect the presence of the SmartClip™ Soft Tissue Marker(s) and provide real-time three-dimensional navigation during the surgery.

DEVICE

EnVisio™ Navigation System

The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClipTM(s) within the surgeon's field of view during the procedure.

Sponsors & Collaborators

  • Elucent Medical

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • M. Catherine Lee, MD · Moffitt Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2023-07-26
Completion
2023-07-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04604561 on ClinicalTrials.gov