COPD (Chronic Obstructive Pulmonary Disease)MCSRETREATNCT07468617
Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
A study testing Metered cryospray (MCS) in people with COPD (Chronic Obstructive Pulmonary Disease) and Chronic Bronchitis, run by CSA Medical, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Chronic Bronchitis
- What is being tested?
- Metered cryospray (MCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2027to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of >30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70
- Subject is being treated according to current medically accepted treatment guidelines for CB for minimum of 3 months prior to enrollment into the study.
- Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study
- Subject is able to adhere to and undergo 2 bronchoscopic procedures per hospital guidelines
Who cannot join
- 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
- Subject has bullous emphysema characterized as large bullae >30 millimeters on High Resolution Computed Tomography (HRCT); or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis
- Subject has clinically significant bronchiectasis as determined by the investigator
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- Subject has had a solid organ transplant procedure
- Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
- Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies
- Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
- Subject is unable to complete patient reported outcome questionnaires due to cognitive impairment, previous cerebral infarct e.g. stroke, TIA
- Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or uncontrolled gastric reflux
- Subject is pregnant, nursing, or planning to get pregnant during study duration
- Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study
- Subject is or has been in another treatment study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)
About this study
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.
Read the detailed description
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.
- Being tested
- Metered cryospray (MCS)
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis, CB, Metered Cryospray, Cryospray, RejuvenAir System
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metered cryospray (MCS)Device
Bronchial metered cryospray (MCS)
| Study group | Role | What they receive |
|---|---|---|
| Metered cryospray (MCS) using the RejuvenAir® System | Experimental | Not described Receives: Device: Metered cryospray (MCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Treatment 1 and Treatment 2
Secondary outcomes (4)
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 ]
Measured: 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 ]
Measured: 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.
Measured: 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.
Measured: Time Frame: 6-months post treatment relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 Jan 2027 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible subjects will receive Metered Cryospray (MCS) treatment
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468617
- Sponsor's protocol ID
- 032
- Acronym
- MCSRETREAT
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: There is no plan at this time.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT07468617
- Acronym / sponsor ID
- MCSRETREAT / 032
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis, CB, Metered Cryospray, Cryospray, RejuvenAir System
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible subjects will receive Metered Cryospray (MCS) treatment
| Arm | Type | Receives |
|---|---|---|
| Metered cryospray (MCS) using the RejuvenAir® System | Experimental | Device: Metered cryospray (MCS) |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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 is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of >30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70
Key exclusion criteria (16 listed)
- 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
- Subject has bullous emphysema characterized as large bullae >30 millimeters on High Resolution Computed Tomography (HRCT); or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metered cryospray (MCS)Bronchial metered cryospray (MCS) | Device | Metered cryospray (MCS) using the RejuvenAir® System |
Primary outcome
Completed MCS treatment applications
Time frame: Treatment 1 and Treatment 2
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].
4 secondary outcomes
The number of serious device-related adverse events
Time frame: Total events within 30 days of Treatment 1 and Treatment 2
The number of serious procedure-related adverse events
Time frame: Total events within 30 days of Treatment 1 and Treatment 2
Patient reported outcome measures using SGRQ Total Score
Time frame: Time Frame: 6-months post treatment relative to baseline
Patient reported outcome measures using CAT Total Score
Time frame: Time Frame: 6-months post treatment relative to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. There is no plan at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Metered cryospray (MCS) in people with COPD (Chronic Obstructive Pulmonary Disease) and Chronic Bronchitis, run by CSA Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completed MCS treatment applications (time frame: Treatment 1 and Treatment 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.