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. * Performance Objective: To collect clinical outcomes and Patient Reported Outcome Measures (PROMs) data (as applicable) on subjects that have undergone surgical breast procedures utilizing one or more Stryker devices. * Safety Objective: To collect data on safety events on the use of Stryker devices and/or related procedures
Study Type
OBSERVATIONAL
Enrollment
5,000
Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Tufts Medical Center
Boston, Massachusetts, United States
Successful marker localization
(proportion of MOLLI markers that are detected intraoperatively)
Time frame: 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)
Time frame: 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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