This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.
Subject has completed a previous MCS study, including both treatments (treatment day 1 and treatment day 2)
Males and females <80 years of age
Subject is able to read, understand, and sign a written informed consent form in order to participate in the study
Subject has a diagnosis of chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) for a minimum of two years. (CB is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
Subject has other origins of respiratory disease aside from CB and COPD
Subject is using e-cigarettes, vaping or inhaled substances not prescribed by a physician
Subject has untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
Single group
Metered cryospray (MCS)
DeviceBronchial metered cryospray (MCS)
Completed MCS treatment applications
Completed MCS treatment applications at Treatment 1 and Treatment 2 defined as \> or = to 80% of fully delivered MCS applications at each procedure. \[Percent of full vs. total applications at each procedure\].
The number of serious device-related adverse events
The number of serious device-related adverse events \[Total events within 30 days of Treatment 1 and Treatment 2 \]
The number of serious procedure-related adverse events
The number of serious procedure-related adverse events \[Total events within 30 days of Treatment 1 and Treatment 2 \]
Patient reported outcome measures using SGRQ Total Score
Patient reported outcome measures using SGRQ Total Score, \[Time Frame: 6-months post treatment relative to baseline \]. SGRQ scores are continuous values ranging from 0 (no symptoms) to 100 (severe symptoms). A reduction in score indicates an improvement.
Patient reported outcome measures using CAT Total Score
Patient reported outcome measures using CAT Total Score, \[Time Frame: 6-months post treatment relative to baseline \]. It provides a standardized score (0-40). A reduction in score indicates an improvement.
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This trial is not recruiting at the moment. You can still explore other options:
