Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Study Overview
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Brief Summary
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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.

Official Title
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Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: EnVisio SmartClip
* Device: EnVisio™ Navigation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving SmartClip<br>Participants will undergo a preoperative physical exam and at least one preoperative ultrasound demonstrating the mass for resection. The SmartClip will be placed under ultrasound guidance. Post-placement mammogram will be obtained after placement of the clip. The SmartClip can be placed up to 30 days prior to the planned surgical resection. At the time of definitive surgery, the Envisio system will be used to identify the clip and the targeted lesion for resection. Intraoperatively, a specimen radiograph will be performed to confirm the presence of the SmartClip and the targeted lesion in the surgical specimen. The breast surgical specimen will be sent for gross examination, including measurements of the tumor in 3 axes. Immediately post-procedure, the performing surgeon will fill out a questionnaire to determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery. | Device: EnVisio SmartClip<br>* 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.<br>Device: EnVisio™ Navigation System<br>* 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.<br>|
| Radiologist Placing SmartClip<br>Radiologist will place SmartClip under ultrasound guidance. A Post-placement mammogram will be obtained after placement of the SmartClip. Immediately post-procedure, the performing radiologist will fill out a questionnaire. | Device: EnVisio SmartClip<br>* 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.<br>Device: EnVisio™ Navigation System<br>* 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.<br>|
| Surgeon<br>The surgeon will use the EnVisio™ Navigation System to identify the SmartClip and the targeted lesion for resection. Immediately post-procedure, the performing surgeon will fill out a questionnaire | Device: EnVisio SmartClip<br>* 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.<br>Device: EnVisio™ Navigation System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placement of the SmartClip on preoperative imaging to clip location on specimen radiography | Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip | 1 year | 
| Placement and visibility of the clip by breast radiologists | Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip | 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 | 1 year | 
| Surgical outcomes with use of the SmartClip | Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SmartClip, EnVisio™ Navigation System