Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

CompletedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

October 27, 2020

Primary Completion Date

July 26, 2023

Study Completion Date

July 26, 2023

Conditions
Breast Cancer
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.

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Elucent Medical

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER