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Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery

RECRUITINGPhase 2Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Actively Recruiting
PhasePhase 2
SponsorH. Lee Moffitt Cancer Center and Research Institute
Started2026-07
Est. completion2028-07
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

Breast CancerCancer

Locations1 site

Moffitt Cancer Center
Tampa, Florida, 33612
Marie Lee, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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