Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

NCT04815291 | Terminated Results FDA Device

• 1 other identifier: SCOUT2021
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Adverse Events

  through study completion; an average of 6 months

• Performance

  through study completion; an average of 6 months

Study Arms (1)

Device

EXPERIMENTAL

Receives SCOUT at biopsy

Device: Receives SCOUT at biopsy

Interventions

Receives SCOUT at biopsy DEVICE

SCOUT Reflector

Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multicentric breast cancer;
• Pregnant or lactating;
• Known or suspected nickel-titanium allergy.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (2)

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

St. Sacrement

Québec, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Casey Holland
• Organization: Merit Medical Systems Inc.

casey.holland@merit.com

6178420251

Study Officials

• C Desbiens, MD

  St. Sacrement

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 25, 2021
• Study Start: April 1, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)