An interventional study of RejuvenAir System and Sham in COPD and Chronic Bronchitis, sponsored by CSA Medical, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by CSA Medical, Inc. · Not applicable, Interventional, and Treatment
To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).
To identify the molecular and cellular targets of MCS treatment and determine the mechanistic relationship to airways remodelling in patients with chronic bronchitis. Phenotype, characterise and correlate clinical, physiological, histological and molecular parameters in patients with chronic bronchitis.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 32 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.
Each Subject must meet the following criteria to be enrolled in the study:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MCS
Device: RejuvenAir System
Sham
Other: Sham
Bronchial metered cryospray using RejuvenAir® System.
Sham control procedure
Goblet cell density
Difference in change relative to baseline in goblet cell density per mm of basement membrane in endobronchial cryobiopsies at 6-months between treatment and sham-control groups
Time frame: 6-months post treatment
Histopathological examination of endobronchial cryobiopsies to determine Inflammatory cells and subtype density per mm of basement membrane
Proportion of inflammatory cells per mm of basement membrane for Neutrophil and Lymphocyte sequencing (RNA-seq)
Time frame: 6-months post treatment
Histopathological examination of endobronchial cryobiopsies to determine epithelial cell density and area (including respiratory epithelial, goblet and basal cells) per mm of basement membrane
Proportion of epithelial cells per mm of basement membrane for Ciliary and Goblet cells
Time frame: 6-months post treatment
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Time frame: 6-months post treatment
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Time frame: 6-months post treatment
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Time frame: 6-months post treatment
Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Time frame: 6-months post treatment
The 6-minute walk tests
The 6-minute walk tests
Time frame: 6-months post treatment
Microvesicle quantification
Microvesicle quantification
Time frame: 6-months post treatment
Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping
Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping
Time frame: 6-months post treatment
Small airways function as assessed by Impulse Oscillometry (IOS)
Small airways function as assessed by Impulse Oscillometry (IOS)
Time frame: 6-months post treatment
Composition of epithelial ultrastructure as assessed by transmission electron microscopy
Composition of epithelial ultrastructure as assessed by transmission electron microscopy
Time frame: 6-months post treatment
Plan to share: Undecided
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 completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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CSA Medical, Inc.