Breast Cancer
Conditions
Keywords
SmartClip, EnVisio™ Navigation System
Brief 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.
Interventions
DEVICEEnVisio 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.
DEVICEEnVisio™ 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
H. Lee Moffitt Cancer Center and Research Institute
Elucent Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target. * Participants must be age \> or = 18 years.
Exclusion criteria
* Participants with sonographically or mammographically occult target lesions * Participants with greater than 35cm chest to bust depth * Participants undergoing mastectomy for resection of the targeted lesion * Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines * Patients requiring use of more than 3 SmartClips to localize targets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort | 1 year | 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. |
| Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Placement of the SmartClip on preoperative imaging to clip location on specimen radiography | 1 year | Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip |
| Placement and visibility of the clip by breast radiologists | 1 year | Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip |
| Intraoperative use of the device system by surgeons | 1 year | Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System |
| Surgical outcomes with use of the SmartClip | 1 year | Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORM. Catherine Lee, MD
Moffitt Cancer Center
Outcome results
None listed