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.
Study Type
OBSERVATIONAL
Enrollment
50
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.
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.
Moffitt Cancer Center
Tampa, Florida, United States
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
Questions 1,2,5,6,7 \& 8 from the Radiologist survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
Time frame: 1 year
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort
Questions 4, 5, 6, 8, 9, 10, \& 11 from the Surgeon survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
Time frame: 1 year
Placement of the SmartClip on preoperative imaging to clip location on specimen radiography
Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip
Time frame: 1 year
Placement and visibility of the clip by breast radiologists
Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip
Time frame: 1 year
Intraoperative use of the device system by surgeons
Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System
Time frame: 1 year
Surgical outcomes with use of the SmartClip
Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System
Time frame: 1 year
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