Cryotherapy Effect Clinical Trial
— FeasibilityOfficial title:
A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
NCT number | NCT02483637 |
Other study ID # | 012 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | May 20, 2022 |
Verified date | February 2023 |
Source | CSA Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 20, 2022 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Netherlands | University Medical Center Groningen | Groningen | |
United Kingdom | Chelsea and Westminster Hosptial/Royal Brompton Hosptial | London |
Lead Sponsor | Collaborator |
---|---|
CSA Medical, Inc. |
Canada, Netherlands, United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exacerbation Rate | Annualized exacerbation rates | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Other | Airway Wall Thickness Using HRCT | Lumen radius in mm. | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Other | Plasma Fibrinogen | 150-400mg/dL | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Primary | 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. | Change from Baseline to 3-Months Following Completion of Treatments | |
Primary | Ability to Complete all 3 MCS Treatments | Number of subjects completing all 3 treatments. | Change from Baseline to 3-Months Following Completion of Treatments | |
Primary | Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ) | Scale is 0-100; a higher score is worse | Change from Baseline to 3-Months Following Completion of Treatments | |
Secondary | Spirometry Testing | FEV1, FEV1/FVC, VC, FIV1 | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Secondary | 6 Minute Walk Test | Number of meters walked in six minutes | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Secondary | Leicester Cough Questionnaire (LCQ) | The total score range is 19-133; a higher score is better. | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Secondary | COPD Assessment Test (CAT) | The total score range is 0-40; a higher score is worse | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Secondary | Visual Analog Scale (VAS) | The total score range is 0-100; a higher score is worse | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | |
Secondary | Modified Medical Research Council (mMRC) | The total score range is 0-4; a higher score is worse | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments |
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