Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery

June 30, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Christine Laronga, MD
        • Sub-Investigator:
          • Nazanin Khakpour, MD
        • Sub-Investigator:
          • John Kiluk, MD
        • Sub-Investigator:
          • Laura Kruper, MD
        • Sub-Investigator:
          • Melissa Mallory, MD
        • Principal Investigator:
          • Marie Lee, MD
        • Sub-Investigator:
          • Brian Czerniecki, MD
        • Sub-Investigator:
          • David Detz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAVI Scout MD Localization
Participants undergo image-guided placement of multiple Scout MD reflectors followed by breast-conserving surgery using the device for intraoperative localization.
Device: SAVI Scout MD system
Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Operation Rate (SOR)
Time Frame: Up to 6 weeks.
Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).
Up to 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Merit Medical

Investigators

  • Principal Investigator: Marie Lee, MD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-24070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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