An interventional study of Metered cryospray (MCS) in COPD (Chronic Obstructive Pulmonary Disease) and Chronic Bronchitis, sponsored by CSA Medical, Inc.. Not yet recruiting. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by CSA Medical, Inc. · Not applicable, Interventional, and Treatment
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.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's planned enrollment of 10 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →CSA Medical, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pulmonary Disease, Chronic Obstructive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Metered cryospray (MCS)
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
No study locations are listed for this record.
Plan to share: Undecided — There is no plan at this time.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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CSA Medical, Inc.