An interventional study of RejuvenAir in Bronchitis, Chronic and Cryotherapy Effect, sponsored by CSA Medical, Inc.. Completed at 3 sites in 3 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by CSA Medical, Inc. · Not applicable, Interventional, and Treatment
This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.
Prospective, open label, single arm study with sequential accrual of subjects with known chronic bronchitis. There are two phases to this study. Phase A will enroll up to 12 subjects and will treat a single lobe to assess safety, feasibility and histology/immunology. After review of the data by the Data Safety Monitoring Board, Phase B of the study would begin. In Phase B of the study, Phase A subjects would have their remaining two lobes treated. In addition up to 24 subjects will be enrolled and will have all upper and lower lobes treated to assess safety, feasibility and immunology.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 30 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.
Counted across the registry records on this site, refreshed daily.
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:
warfarin, Coumadin, LMWH, heparin, clopidogrel (or equal)
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
RejuvenAir treatment of the right lower lobe and right main stem bronchus. Each MCS will be tailored to the bronchial area undergoing treatment and the amount of liquid nitrogen delivered will vary depending on the airway diameter.
Device: RejuvenAir
Device: RejuvenAir
Adverse and Serious Adverse Events
Number of subjects with treatment emergent adverse events. Observed rates and two-sided 95% exact confidence interval will be calculated for AE rates and SAE rates overall and for organ class.
Time frame: Change from Baseline to 3-Months Following Completion of Treatments
Ability to Complete all 3 MCS Treatments
Number of subjects completing all 3 treatments.
Time frame: Change from Baseline to 3-Months Following Completion of Treatments
Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ)
Scale is 0-100; a higher score is worse
Time frame: Change from Baseline to 3-Months Following Completion of Treatments
Spirometry Testing
FEV1, FEV1/FVC, VC, FIV1
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
6 Minute Walk Test
Number of meters walked in six minutes
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Leicester Cough Questionnaire (LCQ)
The total score range is 19-133; a higher score is better.
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
COPD Assessment Test (CAT)
The total score range is 0-40; a higher score is worse
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Visual Analog Scale (VAS)
The total score range is 0-100; a higher score is worse
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Modified Medical Research Council (mMRC)
The total score range is 0-4; a higher score is worse
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Exacerbation Rate
Annualized exacerbation rates
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Airway Wall Thickness Using HRCT
Lumen radius in mm.
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Plasma Fibrinogen
150-400mg/dL
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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CSA Medical, Inc.