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 — DEVICEImplantable 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 LocalizationParticipants 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
- Diane Tendoh813-745-4979
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | 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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