NCT07686250PHASE2Recruiting
Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery
H. Lee Moffitt Cancer Center and Research Institute
Start Date
7/1/2026
Completion Date
7/1/2028
Summary
The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Adult females who are 18 years of age or older at time of signing informed consent will be eligible.
* Must have ability to comprehend and the willingness to sign written informed consent for study participation.
* Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
Exclusion Criteria:
* Patients undergoing mastectomy for resection of the targeted lesion.
* Planned excision of multiple separate sites in the ipsilateral breast.
* Inability to undergo surgery at Moffitt Cancer Center.
Interventions
DEVICE
SAVI Scout MD system
Conditions
Breast Cancer
Locations
Moffitt Cancer Center
Tampa, Florida 33612
United States