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 done through the Medical Device Regulations or the New Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations, that replaced the Interim order on February 27, 2022.
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 # 378905 Authorized under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations |
Effect of Hyperbaric Oxygen Therapy for the treatment of Post COVID Condition | Sechrist 3600H/HR Monoplace Hyperbaric Chamber Sechrist 4100H/HR Monoplace Hyperbaric Chamber |
University Health Network | 2024-07-19 | NCT06452095 |
ITA #357822 | A pilot cross-sectional study evaluating long-term effect of COVID-19 related Acute Respiratory Distress Syndrome (ARDS) on cognition and cerebral vascular reactivity | Respiract RA-MR | Thornhill Research Inc. | 2023-02-23 | N/A |
ITA #342924 Authorized under the Clinical Trials COVID-19 Regulations |
Clinical Evaluation of the Sona Saliva C-19 Rapid Self-Test | Sona Saliva C-19 Rapid Self-Test | Sona Nanotech Inc. | 2022-04-05 | NCT05256589 |
ITA #348963 | Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning LIVE COVID FREE | CMRS Flexible lung Coil | Clinical MR Solutions LLC | 2022-09-23 | N/A |
ITA #329712 Authorized under Clinical Trials Interim Order |
Testing the validity and accuracy of a wireless connected vital sign monitoring bracelet in patients that have COVID-19, have recovered from COVID-19, and in non COVID-19 controls | Zenzers 4Life | iMD Research Inc. | 2021-07-16 | N/A |
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 | NCT04868630 |
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 | NCT048698262 |
ITA #329618 Authorized under Clinical Trials Interim Order |
SpotLight-19 Research and Development (R&D) Study Project | SpotLight-19 | ISBRG Corporation | 2021-04-09 | NCT05198869 |
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 | NCT04877002 |
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 |
ITA #329662 Authorized under Clinical Trials Interim Order |
Multi center, randomized, double-blind, placebo-controlled trial evaluating the feasibility, acceptability, safety and potential effectiveness of adjunctive Photobiomodulation Therapy for COVID-19 pneumonia | SunPowerLED Mini - Canopy | Kerber Applied Research Inc. | 2021-04-30 | N/A |
ITA #331297 Authorized under Clinical Trials Interim Order |
UBC Rapid Testing for Self-Administration among an Asymptomatic Sample | SARS-CoV-2 Antigen Self Test Nasal | Roche Diagnostics | 2021- 05-19 | NCT04896710 |
ITA #330070 | IRCM Post-COVID-19 (IPCO) Clinic: a multidisciplinary approach to evaluate short and long-term complications of COVID-19 | Freestyle Libre Pro Flash Glucose Monitoring System | Abbott Diabetes Care Ltd. | 2021-05-21 | NCT04736732 |
ITA #329614 | Extubation Advisor: initial implementation and evaluation of a novel extubation clinical decision support tool | Extubation Advisor |
OBS Medical Limited | 2021-05-21 | NCT04708509 |
ITA #328878 | LIVE COVID FREE: Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning | 129 Xe Lung Coil | RAPID Biomedical GmbH | 2021-05-24 | NCT04584671 |
ITA #330308 | Lung Structure-Function In SurVivors of Mild and SEvere COVID19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning (Short title: LIVE COVID FREE) | Lung Coil for Hyperpolarized Gas | RAPID Biomedical GmbH | 2021-06-07 | NCT05014516 |
ITA #330208 | Lung Structure-Function In SurVivors of Mild and SEvere COVID19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning (Short title: LIVE COVID FREE) | CMRS Flexible Lung Coil | Clinical MR Solutions LLC | 2021-06-07 | NCT05014516 |
ITA #330833 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 EDTA Plasma Samples When Tested with the Lumivi Diagnostics™ SARS CoV-2 IgG Rapid Test | Lumivi Diagnostics SARS CoV-2 IgG Rapid Test | International Point of Care Inc. | 2021-06-11 | N/A |
ITA #332004 Authorized under Clinical Trials Interim Order |
A Multi Center, Point of Care Study to Evaluate the Usability of the Lumivi Diagnostic SARS CoV-2 IgG Rapid Test in the Intended Use Environment | Lumivi Diagnostics SARS CoV-2 IgG Rapid Test | International Point of Care Inc. | 2021-07-13 | N/A |
ITA #334693 |
A Multi-Center Evaluation of Buccal Swabs with the Abbott ID NOW COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments | ID NOW COVID-19 | The Governors of the University of Calgary | 2021-09-03 | NCT05040763 |
ITA #329700 |
POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva | COVID-19 Rapid Antigen Test | Therma Bright Inc. | 2021-09-16 | NCT04878068 |
ITA #337438 Authorized under Clinical Trials Interim Order |
Low-cost sensor system for COVID-19 patient monitoring: Validation of BRAEBON Vital Signs Monitor (VTS) | BRAEBON Vital Signs Monitor | BRAEBON Medical Corporation | 2021-12-14 | NCT05029011 |
ITA #336048 | Impact of COVID-19 on cerebral health measured with quantitative MRI | RA-MR System | Thornhill Research Inc. | 2021-12-22 | N/A |
ITA #338392 Authorized under Clinical Trials Interim Order |
POC study to evaluate the performance of the RAMP COVID-19 Antigen Test for detection of SARS-CoV-2 Virus in symptomatic nasal swab specimens (POCCAT Study) | RAMP COVID-19 ANTIGEN TEST | RESPONSE BIOMEDICAL CORPORATION | 2021-12-31 | N/A |
ITA #338359 |
A decentralized trial to determine the degree of concordance between COVISTIX™ results and an authorized RT-PCR test's results for in vitro qualitative detection of the SARS-CoV-2 Antigen for both Point of Care and Self-Testing (At Home Use) | COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test | DICENTRA INCORPORATED | 2022-01-25 | N/A |
ITA #343212 Authorized under the Clinical Trials COVID-19 Regulations |
Clinical Performance Evaluation of COVID-19 Antigen Home Test | COVID-19 Antigen Home Test | DICENTRA INCORPORATED | 2022-03-16 | N/A |
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