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Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
The purpose of this study is to leverage standard of care data on clinical outcomes following surgical procedures as indicated for each device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Surgical Procedures | Patients who have undergone breast surgical procedure (per product indications for use) using the Stryker device who meet all of the following criteria will be screened and enrolled by participating Investigators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care treatment | Device | Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful marker localization | (proportion of MOLLI markers that are detected intraoperatively) | From the start of surgery to completion of surgery for each participant (assessed intraoperatively, up to the duration of the surgical procedure, typically within the same day) |
| Marker retrieval success | (proportion of procedures in which the MOLLI marker is removed within the surgical specimen) | From the start of surgery to completion of surgery for each participant (assessed intraoperatively, up to the duration of the surgical procedure, typically within the same day) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone a surgical procedure using the Stryker device(s) who meet all of the eligibility criteria will be screened and enrolled by participating Investigators.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prajakta Sawwalakhe, MD | Contact | 16692077970 | prajakta.sawwalakhe@stryker.com | |
| Colleen Roden | Contact | 9312672041 | colleen.roden@stryker.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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