Clinical Studies

Clinical Studies

 

The simplicity, safety and effectiveness of the Hemolung Respiratory Assist System (RAS) have been demonstrated in use at more than 100 hospitals worldwide. The device is approved in 34 countries outside of the US, including Canada and Australia.

 

ALung Technologies is the only company engaged in two landmark pivotal clinical trials regarding the treatment of patients with acute respiratory failure.

 

VENT-AVOID TRIAL

The VENT-AVOID Trial is a U.S.-based clinical trial to validate the safety and efficacy of the Hemolung RAS for the treatment of adults with severe acute exacerbation of chronic obstructive pulmonary disease (COPD).  The U.S. FDA’s approval of its Investigational Device Exemption (IDE) makes ALung’s VENT-AVOID Trial the first pivotal trial of ECCO2R for treating patients with COPD exacerbations.  Forty-five hospitals will enroll up to 180 patients in the trial, which was launched in 2017.  

 

REST Trial

The REST Trial has concluded with 412 patients enrolled over 40 sites including 204 therapies run on the Hemolung Respiratory Assist Systems (RAS).   Located in the United Kingdom, the study was funded by the UK National Institute for Health Research (NIHR) and focused on patients with acute respiratory syndrome (ARDS).  The REST Trial, which launched in 2015, was the first and largest randomized pivotal ECCO2R clinical trial ever conducted.  More information will be available as the trial data is analyzed and published by the REST Trial investigators.