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Medical Device

Low-Cost ECG Validation for ECG Accuracy

N/A

Waitlist Available

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1: Healthy > 18 years of age

Phase 2: > 18 years of age non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 seconds

Awards & highlights

Study Summary

This trial will test whether a low-cost ECG device is as accurate as a more expensive one.

Who is the study for?

This trial is for adults over 18 who can consent to participate. Phase 1 includes healthy individuals, while Phase 2 involves non-critical patients with heart issues in the emergency department. It excludes critical patients, those under 18, and in Phase 1, people over 70 or with a history of cardiac disease.Check my eligibility

What is being tested?

The study is testing a new low-cost ECG device against a gold standard hospital-grade one to see if it's just as good. The goal is to make this vital heart-monitoring tech more accessible, especially in underserved areas.See study design

What are the potential side effects?

Since this trial involves testing an ECG device rather than medication or invasive procedures, side effects are minimal but may include discomfort from electrode placement or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and healthy.

Select...

I am over 18 and went to the ER with a heart problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 seconds

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 seconds

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 seconds for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study deviceExperimental Treatment1 Intervention

Group II: Control deviceActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

658 Previous Clinical Trials

413,208 Total Patients Enrolled

Media Library

Open-Source Electrocardiograph (Medical Device) Clinical Trial Eligibility Overview. Trial Name: NCT04209062 — N/A

Electrocardiogram (ECG) Research Study Groups: Control device, Study device

Electrocardiogram (ECG) Clinical Trial 2023: Open-Source Electrocardiograph Highlights & Side Effects. Trial Name: NCT04209062 — N/A

Open-Source Electrocardiograph (Medical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209062 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this experimental procedure open?

"This study is recruiting 450 individuals ranging from 18 to 70 years of age who have a cardiac complaint, and meet the other criteria such as being able to provide informed consent. This two-phase trial will take place at Victoria Hospital and University Hospital in the Emergency Department for non-critical patients."

Answered by AI

Does this experiment have an age ceiling of 50 or below?

"In line with the conditions for entry, only individuals between 18 and 70 years old are eligible to participate in this medical trial."

Answered by AI

Is it yet feasible to apply for this research endeavor?

"According to clinicaltrials.gov, this medical trial is not currently recruiting patients as the last edit was made on August 24th 2022. Nonetheless, there are 3 other active trials that may require participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Tarek Loubani, MD 2023. "Validation of a High-Quality Low-Cost Open-Source Electrocardiograph". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04209062.