Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Device: Receives SCOUT at biopsy

• Registration Number: NCT04815291
• Lead Sponsor: Merit Medical Systems, Inc.

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 Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-25
• Study Start: 2022-04-01
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Results First Submitted: 2024-03-21
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	Receives SCOUT at biopsy	Receives SCOUT at biopsy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Number of Participants With Adverse Events	through study completion; an average of 6 months	Device-related adverse event rate

Trial Locations

Locations (2)

Centre Hospitalier de l'Universite de Montreal (CHUM); 🇨🇦 Montréal, Quebec, Canada

St. Sacrement; 🇨🇦 Quebec, Canada