Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT02483637
• Date of registration: 25/06/2015
• Prospective Registration: Yes
• Primary sponsor: CSA Medical, Inc.
• Public title: Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients Feasibility
• Scientific title: A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
• Date of first enrolment: February 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02483637
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, Germany, Ireland, Netherlands, United Kingdom

Contacts

• Name: Heather Nigro
• Affiliation: CSA Medical

Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bronchitis, Chronic

Cryotherapy Effect

Intervention(s)

Device: RejuvenAir

Primary Outcome(s)

Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ) [Time Frame: Change from Baseline to 3-Months Following Completion of Treatments]

Ability to Complete all 3 MCS Treatments [Time Frame: Change from Baseline to 3-Months Following Completion of Treatments]

Adverse and Serious Adverse Events [Time Frame: Change from Baseline to 3-Months Following Completion of Treatments]

Secondary Outcome(s)

6 Minute Walk Test [Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments]

Spirometry Testing [Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments]

Visual Analog Scale (VAS) [Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments]

COPD Assessment Test (CAT) [Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments]

Leicester Cough Questionnaire (LCQ) [Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments]

Modified Medical Research Council (mMRC) [Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments]

Secondary ID(s)

012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors