Sponsor decision.

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.

Inclusion Criteria:

1. Woman >18 years and < 80 years of age;
2. Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
3. Lesion depth is < 6 cm from skin surface;
4. Non-palpable lesions;
5. Informed consent obtained.

Exclusion Criteria:

1. Multicentric breast cancer;
2. Pregnant or lactating;
3. Known or suspected nickel-titanium allergy.

Although 93 subjects were enrolled as the overall number of baseline participants, there was one participant that did not have available data.

Adverse events were collected through study completion; average of 6 months.

The following adverse events of interest and device deficiencies were collected: Adverse reaction to material, Device Migration, Inaccurate location detection, Inaccurate deployment, Infection Tissue/vascular trauma, and any AE that, in the opinion of the investigator, has a causal relationship (probable or definite) to the device or procedure, or any device deficiency, whether or not associated with an adverse event. All AEs collected were treatment related.