Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery

NCT07686250 | Recruiting Phase 2 FDA Device

• 1 other identifier: MCC-24070
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Successful Operation Rate (SOR)

  Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).

  Up to 6 weeks.

Study Arms (1)

SAVI Scout MD Localization

EXPERIMENTAL

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

Interventions

SAVI Scout MD system DEVICE

Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.

SAVI Scout MD Localization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Merit Medical: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marie Lee, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Tendoh

CONTACT

813-745-4979; Diane.Tendoh@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)