Conducting a clinical trial for COVID-19 medical devices: List of authorized clinical trials

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is through the Medical Device Regulations or the interim order for clinical trials for medical devices and drugs related to COVID-19.

Health Canada continues to discuss potential clinical trials with a number of sponsors. We will update the list as new trials related to medical devices are authorized.

Trial Name /Protocol #/control # Title Medical device name Authorization holder Authorization date Link
ITA #287025 Continuous Negative Abdominal Pressure in Acute Respiratory Distress Syndrome (CNAP in ARDS) Continuous Negative Abdominal Pressure (CNAP) System The Hospital for Sick Children March 26, 2020 NCT03425318
ITA #313362 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents with Non-Tuberculous Mycobacteria, Burkholderia spp, Aspergillus spp and Corona-like Viral (Sub-Study) Infections Inhaled Nitric Oxide Delivery Device (INODD) 12th Man Technologies April 7, 2020 N/A
ITA #314979 Evaluating Auscul-X, a Touch Free Digital Stethoscope, for Physical Distancing to Protect Patients and Health Care Professionals from COVID-19 (The Auscul-X Study) Auscul-X Touchless Stethoscope System AusculSciences Canada Inc. May 19, 2020 NCT04570189
ITA #313883 Inhaled NO for the Treatment of COVID-19 caused by SARS-CoV-2 LungFit Bro Beyond Air, Inc. May 22, 2020 NCT04456088
ITA #312830 Novel diagnostic and imaging strategies for early detection and surveillance of COVID-19 in the lung using artificial intelligence REVEAL 35C Flat Panel Detector KA Imaging Inc. June 12, 2020 N/A
ITA #315695 Evaluation of Clinical Sample Collection The Spartan COVID-19 System Spartan Bioscience Inc. June 23, 2020 NCT04473248
ITA #316832
Authorized under Clinical Trials Interim Order
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted with COVID-19 Inhaled Nitric Oxide Delivery Device (INODD) 12th Man Technologies July 10, 2020 NCT04383002
ITA #317427
Authorized under Clinical Trials Interim Order
Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study smartphone rPPG Carebrook Technologies Inc. July 13, 2020 NCT04489407
ITA #317693
Authorized under Clinical Trials Interim Order
A Multi Center, Point of Care, Near Patient Study to Evaluate the Usability of the Nadal COVID-19 IgG/IgM Test In the Intended Use Environment Nadal COVID-19 IgG/IgM Test Luminarie Canada Inc. July 24, 2020 N/A
ITA #317236
Authorized under Clinical Trials Interim Order
COSMIC Bubble Helmet Non-Invasive Positive Pressure Ventilation in the Treatment of COVID-19 Patients - Feasibility Clinical Trial Cosmic Bubble Helmet Cosmic Technologies Inc. July 28, 2020 N/A
ITA #315768 A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms Vielight RX Plus Vielight Inc. September 2, 2020 NCT04418505
ITA #318909 Calibration of the Average Breathing Rate Measurement of the Cloud Dx Pulsewave Health Monitor (PAD-2A) Device (CCV-3) Pulsewave Health Monitor Cloud DX Inc. October 6, 2020 N/A
ITA #321106
Authorized under Clinical Trials Interim Order
Assess the performance of Spartan COVID-19 V2 System in a clinical setting in comparison to a laboratory (standard of care (SOC)) PCR Method (Canada Alternate)
Short title: Clinical Study Spartan COVID-19 V2 System (Canada Alternate)
The Spartan COVID-19 V2 System Spartan Bioscience Inc. October 29, 2020 NCT04575168
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