Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
NCT ID: NCT04604561
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2020-10-27
2023-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Participants receiving 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.
EnVisio 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.
EnVisio™ 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.
Radiologist Placing 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.
EnVisio 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.
EnVisio™ 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.
Surgeon
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
EnVisio 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.
EnVisio™ 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.
Interventions
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EnVisio 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.
EnVisio™ 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.
Eligibility Criteria
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Inclusion Criteria
* Participants must be age \> or = 18 years.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Elucent Medical
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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M. Catherine Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Related Links
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Moffitt Cancer Center Clinical Trial Search
Other Identifiers
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MCC-20335
Identifier Type: -
Identifier Source: org_study_id
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