This study evaluates the use of devices, the SmartClip soft tissue marker and EnVisio Navigating System for identifying breast masses before surgery. The SmartClip soft tissue marker is placed to identify a breast mass. The EnVisio Navigation System is a medical device that provides real-time three-dimensional navigation during surgery by detecting the presence of the SmartClip soft tissue marker. The SmartClip soft tissue marker and EnVisio Navigating System may provide better resources for surgeons to correctly localize breast masses during surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT04604561.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the ability of localizing in-breast lesions using the EnVisio Navigation and SmartClip system in surgery.
SECONDARY OBJECTIVES:
I. To compare the placement of the SmartClip on preoperative imaging to clip location on specimen radiography.
II. To evaluate placement and visibility of the clip by breast radiologists.
III. To evaluate intraoperative use of the device system by surgeons.
IV. To evaluate surgical outcomes (margins, specimen size, length of operation) with use of the SmartClip.
OUTLINE:
Patients undergo placement of SmartClip soft tissue marker (SmartClip) up to 30 days prior to standard of care surgical resection. Patients then undergo surgical resection using EnVisio Navigation System to identify SmartClip placement.
Radiologists complete a questionnaire after SmartClip placement, and surgeons complete a questionnaire following surgical resection with EnVisio Navigation System.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorMarie Catherine Lee
