STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Merit Medical Systems, Inc.
- Enrollment
- 93
- Locations
- 2
- Primary Endpoint
- Number of Participants Invasive Visits
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Woman >18 years and < 80 years of age;
- •Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
- •Lesion depth is < 6 cm from skin surface;
- •Non-palpable lesions;
- •Informed consent obtained.
Exclusion Criteria
- •Multicentric breast cancer;
- •Pregnant or lactating;
- •Known or suspected nickel-titanium allergy.
Arms & Interventions
Device
Receives SCOUT at biopsy
Intervention: Receives SCOUT at biopsy (Device)
Outcomes
Primary Outcomes
Number of Participants Invasive Visits
Time Frame: through study completion, an average of 6 months
Number of visits to the breast centre for an invasive procedure between biopsy and surgery
Secondary Outcomes
- Performance(through study completion; an average of 6 months)
- Number of Participants With Adverse Events(through study completion; an average of 6 months)