Standard of care treatment: Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Study summary
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subject was ≥ 18 years of age at the time of the surgery
* Patients who have undergone breast surgical procedures using MOLLI, SPY-PHI, and/or SPY AGENT GREEN
Exclusion Criteria:
* Subjects who are less than 1-month post-intervention
* Concurrent participation in an interventional investigational clinical study at the time of initial surgery
* Subjects whose surgery date was prior to January 2022.
* Pregnant or lactating females at the time of initial surgery
Primary outcome measure(s)
Successful marker localization — 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) (proportion of MOLLI markers that are detected intraoperatively)
Marker retrieval success — 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) (proportion of procedures in which the MOLLI marker is removed within the surgical specimen)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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