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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

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Conditions

Breast Cancer

Locations

Moffitt Cancer Center

Tampa, Florida 33612

United States