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 NCT04699942
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
ITA #329618
Authorized under Clinical Trials Interim Order
SpotLight-19 Research and Development (R&D) Study Project SpotLight-19 ISBRG Corporation 2021-04-09 N/A
ITA #329248
Authorized under Clinical Trials Interim Order
Novel Salivary Rapid Testing of SARS-CoV-2 Sona Saliva C-19 Rapid Test Sona Nanotech Inc. 2021-04-12 N/A
ITA #329256
Authorized under Clinical Trials Interim Order
A Single-Center, Point of Care, Comparative Study to Evaluate the Equivalence of the Test Results for Capillary Whole Blood, Venous Whole Blood and Serum or Plasma Samples When Tested With the Nadal COVID-19 IgG/IgM Test Nadal COVID-19 IgG/IgM Test Teracero Pharma Inc. 2021-04-13 N/A
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