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 Clinicaltrials.gov Link
ITA #322514
Authorized under Clinical Trials Interim Order
REOM in COVID-19: Rapid expiratory occlusion monitor in SARS-CoV-2 Infection.  Evaluation of a novel approach for self-administered home monitoring of respiratory function in COVID-19 patients. REO Monitor Thorasys Thoracic Medical Systems Inc. 2020-11-26 N/A
ITA #322374
Authorized under Clinical Trials Interim Order
Prevention of COVID-19 with Oral Vitamin D supplemental Therapy in Essential healthCare Teams (PROTECT trial) Nadal COVID-19 IgG/IgM Test Luminarie Canada Inc. 2020-11-14 NCT04483635
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. 2020-10-29 NCT04575168
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. 2020-10-06 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. 2020-09-02 NCT04418505
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. 2020-07-28 N/A
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. 2020-07-24 N/A
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. 2020-07-13 NCT04489407
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 2020-07-10 NCT04383002
ITA #315695 Evaluation of Clinical Sample Collection The Spartan COVID-19 System Spartan Bioscience Inc. 2020-06-23 NCT04473248
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. 2020-06-12 N/A
ITA #313883 Inhaled NO for the Treatment of COVID-19 caused by SARS-CoV-2 LungFit Bro Beyond Air, Inc. 2020-05-22 NCT04456088
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. 2020-05-19 NCT04570189
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 2020-04-07 N/A
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 2020-03-26 NCT03425318
ITA #322424
Authorized under Clinical Trials Interim Order
PRevention of COVID-19 with Oral Vitamin D supplemental Therapy in Essential healthCare Teams (PROTECT trial) TASSO-SST Tasso, Inc. 2020-12-02 NCT04483635
ITA #324553
Authorized under Clinical Trials Interim Order
Pilot Study to evaluate the Revoxa system in Hypoxic Patients Revoxa Oxygen Rebreather Ironstone Product Development Inc. 2020-12-07 N/A
ITA #326341 Calibration of the Cloud Dx Pulsewave Health Monitor (PAD-2A) oscillometric wrist cuff home blood pressure monitor, according to the Association for the Advancement of Medical Instrumentation/ European Society of Hypertension / International Organization for Standardization Universal Standard (ISO 81060-2) (CCV-4) Pulsewave Health Monitor Cloud DX Inc. 2020-12-31 N/A
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