NCT04209062

Validation of a High-Quality Low-Cost Open-Source Electrocardiograph

Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The high price of electrocardiograph (ECG) devices - with most hospital-grade devices costing thousands of dollars - is one of the barriers to access of this vital technology. There is a shortage of ECG devices in underserved areas and the devices available on the market currently are not adequate to solve this problem. Our solution is a low-cost high-quality open-access ECG device. This study intends to validate the study ECG device in human patients by demonstrating equivalence between the study ECG device and a gold standard device.

Conditions

• Open Access
• Medical Devices
• Low Cost
• Electrocardiograph

Interventions

Type	Name	Description
DEVICE	Medical device validation	The medical devices will both record electrical signals for comparison

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-31
• Completion: 2024-07-01
• First posted: 2019-12-23
• Last updated: 2022-08-25

Locations

1 site across 1 country: Canada