Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

Breast Cancer Clinical Trial

Official title:

STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04815291
• Other study ID #: SCOUT2021
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: May 2024
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Receives SCOUT at biopsy
SCOUT Reflector

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montréal	Quebec
Canada	St. Sacrement	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Invasive Visits	Number of visits to the breast centre for an invasive procedure between biopsy and surgery	through study completion, an average of 6 months
Secondary	Number of Participants With Adverse Events	Device-related adverse event rate	through study completion; an average of 6 months
Secondary	Performance	Successful Procedure is absence of close margins (<2mm), positive margins (tumor on ink) or requirement for re-excision.	through study completion; an average of 6 months