Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Receives SCOUT at biopsy

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • St. Sacrement
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; Receives SCOUT at biopsy	Device: Receives SCOUT at biopsy; SCOUT Reflector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Device-related adverse event rate	through study completion; an average of 6 months
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

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Investigators: Principal Investigator: C Desbiens, MD, St. Sacrement

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SCOUT2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes