Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07686250
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAVI Scout MD system — DEVICE
    Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Successful Operation Rate (SOR) [ Time Frame: Up to 6 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Marie Lee, MD (PRINCIPAL_INVESTIGATOR)
Brian Czerniecki, MD (SUB_INVESTIGATOR)
David Detz, MD (SUB_INVESTIGATOR)
Nazanin Khakpour, MD (SUB_INVESTIGATOR)
John Kiluk, MD (SUB_INVESTIGATOR)
Laura Kruper, MD (SUB_INVESTIGATOR)
Christine Laronga, MD (SUB_INVESTIGATOR)
Melissa Mallory, MD (SUB_INVESTIGATOR)

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