Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEReceives SCOUT at biopsy
SCOUT Reflector
Sponsors
Merit Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Invasive Visits | through study completion, an average of 6 months | Number of visits to the breast centre for an invasive procedure between biopsy and surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | through study completion; an average of 6 months | Device-related adverse event rate |
| Performance | through study completion; an average of 6 months | Successful Procedure is absence of close margins (\<2mm), positive margins (tumor on ink) or requirement for re-excision. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Receives SCOUT at biopsy
Receives SCOUT at biopsy: SCOUT Reflector | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Surgery not planned and subject not operated. | 3 |
Baseline characteristics
| Characteristic | Device | — |
|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 8.47 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 92 participants | — |
| Sex: Female, Male Female | 92 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 93 |
| other Total, other adverse events | 1 / 93 |
| serious Total, serious adverse events | 0 / 93 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants Invasive Visits | 5 Participants |
Secondary
Number of Participants With Adverse Events
Device-related adverse event rate
Time frame: through study completion; an average of 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Adverse Events | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Performance | 84 Participants |