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 #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

N/A

ITA #313883 Inhaled NO for the Treatment of COVID-19 caused by SARS-CoV-2 LungFit Bro Beyond Air, Inc. May 22, 2020 N/A
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