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| Name | Class |
|---|---|
| Merit Medical | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAVI Scout MD system | Device | Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane Tendoh | Contact | 813-745-4979 | Diane.Tendoh@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Marie Lee, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |