Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

Merit Medical Systems

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: Receives SCOUT at biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04815291

SCOUT2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

Device

Experimental group

Description:

Receives SCOUT at biopsy

Treatment:

Device: Receives SCOUT at biopsy