This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.
This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
SCOUT Reflector
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
St. Sacrement
Québec, Canada
Number of Participants Invasive Visits
Number of visits to the breast centre for an invasive procedure between biopsy and surgery
Time frame: through study completion, an average of 6 months
Number of Participants With Adverse Events
Device-related adverse event rate
Time frame: through study completion; an average of 6 months
Performance
Successful Procedure is absence of close margins (\<2mm), positive margins (tumor on ink) or requirement for re-excision.
Time frame: through study completion; an average of 6 months
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