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Freezing lung lining again? small study tests repeat cryospray safety in COPD

NCT ID NCT07468617

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether it is safe to repeat a procedure called metered cryospray in people with COPD and chronic bronchitis who have already had it once. Only 10 participants will be enrolled. The main goal is to see if the treatment can be fully delivered and to track any serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metered cryospray (device)
What this could lead to
If safe, this could offer a repeatable procedure to ease chronic bronchitis symptoms in COPD patients.
What could go wrong
This is a very small safety study (10 people) with no control group. It only tests if repeat treatment is safe, not if it works. Risks include serious device- or procedure-related adverse events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject has completed a previous MCS study, including both treatments (treatment day 1 and treatment day 2) 2. Males and females \<80 years of age 3. Subject is able to read, understand, and sign a written informed consent form in order to participate in the study 4. 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) 5. 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 6. Subject is being treated according to current medically accepted treatment guidelines for CB for minimum of 3 months prior to enrollment into the study. 7. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study 8. Subject is able to adhere to and undergo 2 bronchoscopic procedures per hospital guidelines Exclusion Criteria: 1. 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 2. Subject has other origins of respiratory disease aside from CB and COPD 3. Subject is using e-cigarettes, vaping or inhaled substances not prescribed by a physician 4. Subject has untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure 5. 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 6. Subject has clinically significant bronchiectasis as determined by the investigator 7. Subject has had a solid organ transplant procedure 8. Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery 9. Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies 10. Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal) 11. Subject is unable to complete patient reported outcome questionnaires due to cognitive impairment, previous cerebral infarct e.g. stroke, TIA 12. 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 13. Subject is pregnant, nursing, or planning to get pregnant during study duration 14. 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 15. 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 16. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  2. A doctor treating you

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