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.
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. This is an open-label study. Eligible subjects will have previously completed the SPRAYCB study (NCT03893370). Subjects will receive 2 sessions of bronchial metered cryospray using RejuvenAir® System. Each session will be separated by approximately 30-45 days. Subjects will be followed at 3-month and at 6-months post second procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Bronchial 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. \[Percent of full vs. total applications at each procedure\].
Time frame: Treatment 1 and Treatment 2
The number of serious device-related adverse events
The number of serious device-related adverse events \[Total events within 30 days of Treatment 1 and Treatment 2 \]
Time frame: 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 \[Total events within 30 days of Treatment 1 and Treatment 2 \]
Time frame: 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.
Time frame: Time Frame: 6-months post treatment relative to baseline
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.
Time frame: Time Frame: 6-months post treatment relative to baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.