Open AccessNCT04209062
Validation of a High-Quality Low-Cost Open-Source Electrocardiograph
A study testing Medical device validation in people with Open Access and Medical Devices, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Access, Medical Devices, Low Cost
- What is being tested?
- Medical device validation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.
- 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
Who cannot join
- < 18 years old
- Unable to consent
- Phase 1:
- > 70 years of age
- Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
- current status of non-sinus heart rhythm
- Phase 2:
- Critical patients in the ED where consent would inappropriately delay investigations or treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)
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
- Being tested
- Medical device validation
- Keywords
- Open Access, Medical Devices, Low Cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical device validationDevice
The medical devices will both record electrical signals for comparison
| Study group | Role | What they receive |
|---|---|---|
| Study device | Experimental | Not described Receives: Device: Medical device validation |
| Control device | Active comparator | Not described Receives: Device: Medical device validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG
Comparing electrical signals from ECG electrodes with tested device and gold standard device by collecting the following data from both devices: rate, QR interval, PR interval, QT interval, and rhythm.
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Loubani, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209062
- Sponsor's protocol ID
- 112365
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2018
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)
- ClinicalTrials.gov ID
- NCT04209062
- Acronym / sponsor ID
- 112365
- Conditions
- Open Access, Medical Devices, Low Cost, Electrocardiograph
- Keywords
- Open Access, Medical Devices, Low Cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study device | Experimental | Device: Medical device validation |
| Control device | Active comparator | Device: Medical device validation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.
- Healthy
- > 18 years of age
- > 18 years of age
- non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint
Key exclusion criteria (8 listed)
- < 18 years old
- Unable to consent
- > 70 years of age
- Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
- current status of non-sinus heart rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical device validationThe medical devices will both record electrical signals for comparison | Device | Control device, Study device |
Primary outcome
Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG
Time frame: 60 seconds
Comparing electrical signals from ECG electrodes with tested device and gold standard device by collecting the following data from both devices: rate, QR interval, PR interval, QT interval, and rhythm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical device validation in people with Open Access and Medical Devices, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek Loubani, MD (15196858500 ext. 54970, tarek@tarek.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.