NCT04815291

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Receives SCOUT at biopsy	SCOUT Reflector

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2021-03-25
• Last updated: 2024-05-21
• Results posted: 2024-05-21

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study