Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients (Feasibility)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02483637 |
Recruitment Status :
Active, not recruiting
First Posted : June 29, 2015
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bronchitis, Chronic Cryotherapy Effect | Device: RejuvenAir | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | RejuvenAir |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients |
Study Start Date : | February 2016 |
Actual Primary Completion Date : | May 2019 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: RejuvenAir
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.
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Device: RejuvenAir
Device: RejuvenAir |
- Adverse and Serious Adverse Events [ Time Frame: Change from Baseline to 3-Months Following Completion of Treatments ]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.
- Ability to Complete all 3 MCS Treatments [ Time Frame: Change from Baseline to 3-Months Following Completion of Treatments ]Number of subjects completing all 3 treatments.
- Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Change from Baseline to 3-Months Following Completion of Treatments ]Scale is 0-100; a higher score is worse
- Spirometry Testing [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]FEV1, FEV1/FVC, VC, FIV1
- 6 Minute Walk Test [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]Number of meters walked in six minutes
- Leicester Cough Questionnaire (LCQ) [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]The total score range is 19-133; a higher score is better.
- COPD Assessment Test (CAT) [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]The total score range is 0-40; a higher score is worse
- Visual Analog Scale (VAS) [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]The total score range is 0-100; a higher score is worse
- Modified Medical Research Council (mMRC) [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]The total score range is 0-4; a higher score is worse
- Exacerbation Rate [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]Annualized exacerbation rates
- Airway Wall Thickness Using HRCT [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]Lumen radius in mm.
- Plasma Fibrinogen [ Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments ]150-400mg/dL

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females ≥40 to ≤75 years of age.
- Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study.
- Subject agrees to continue maintenance pulmonary/COPD medications for the duration of the study.
- Diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years. (Chronic Bronchitis 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.)
- Pre-procedure post bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within 3 months of enrollment.
- Smoking history of at least 10 pack years.
- Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study.
- Subject is able to adhere to and undergo 3 (4 if in Phase A) bronchoscope procedures that includes lung biopsies and multiple MCS treatments in the opinion of the investigator
Exclusion Criteria:
- Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks of study bronchoscopy.
- Subject has had a CB and/or COPD exacerbation (requiring steroids and/or antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their treating physician
- Subject has clinically significant bronchiectasis or other respiratory disease other than chronic bronchitis and COPD.
- Diagnosis of asthma with an onset before 30 years of age
- Subject has bullous emphysema characterized as large bullae >30 millimeters on CT.
- Subject has had a transplant.
- Subject has the inability to walk >140 meters
- Subject has PaC02 >8kPa, or a PaO2<7kPa at room air.
- Subject has a RVSP >45mmHg or a LVEF<45% on 2D-cardiac echo.
- Subject has undergone lung surgery: pneumonectomy, lobectomy, bullectomy, lung volume reduction surgery
- Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation or other devices for emphysema.
- Subject is unable to temporarily discontinue use of anticoagulant therapy:
warfarin, Coumadin, LMWH, heparin, clopidogrel (or equal)
- Subject is on >10 mg of prednisolone/day.
- Subject has a serious medical condition, such as: 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, hypertension, autoimmune disease or uncontrolled gastric reflux
- Subject is pregnant, nursing, or planning to get pregnant during study duration.
- Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
- Subject is or has been in another clinical investigational study within 6 weeks of baseline.
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
- Subject has been in another clinical investigational study within 6 weeks of baseline.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483637
Canada, British Columbia | |
St. Paul's Hospital | |
Vancouver, British Columbia, Canada | |
Netherlands | |
University Medical Center Groningen | |
Groningen, Netherlands | |
United Kingdom | |
Chelsea and Westminster Hosptial/Royal Brompton Hosptial | |
London, United Kingdom, SW10 9NH |
Study Director: | Heather Nigro | CSA Medical |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | CSA Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT02483637 |
Other Study ID Numbers: |
012 |
First Posted: | June 29, 2015 Key Record Dates |
Last Update Posted: | March 9, 2022 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
spray cryotherapy cryotherapy chronic bronchitis airflow restrictions |
Bronchitis Bronchitis, Chronic Acute Disease Respiratory Tract Infections Infections Bronchial Diseases |
Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Disease Attributes Pathologic Processes Pulmonary Disease, Chronic Obstructive |