Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
Completed
- Conditions
- Breast Cancer
- Interventions
- Device: EnVisio SmartClipDevice: EnVisio™ Navigation System
- Registration Number
- NCT04604561
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgeon EnVisio SmartClip 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 Surgeon EnVisio™ Navigation System 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 Participants receiving SmartClip EnVisio™ Navigation System 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. Radiologist Placing SmartClip EnVisio™ Navigation System 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. Participants receiving SmartClip EnVisio SmartClip 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. Radiologist Placing SmartClip EnVisio SmartClip 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States