{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"}],"units":"Participants"}],"description":"Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period","groups":[{"description":"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.\n\nPatients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.\n\nNewBreez: Intralaryngeal prosthesis to protect the airways","id":"OG000","title":"NewBreez"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2 weeks","title":"Number of Reported Adverse Events","type":"SECONDARY","unitOfMeasure":"AE reported"}