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Trial record 1 of 1 for:    NCT02483637
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Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients (Feasibility)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by CSA Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02483637
First received: June 25, 2015
Last updated: January 16, 2017
Last verified: January 2017
  Purpose
This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.

Condition Intervention Phase
Bronchitis, Chronic
Cryotherapy Effect
Device: RejuvenAir
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients

Resource links provided by NLM:


Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • Adverse and Serious Adverse Events [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • Histologic appearance of bronchial biopsies in Phase A subjects [ Time Frame: 60 days ]
  • Airway wall thickness using high resolution computed tomography (HRCT) [ Time Frame: 3 years ]

Estimated Enrollment: 15
Study Start Date: February 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: RejuvenAir
Device: RejuvenAir

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, clopidrogel (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02483637

Contacts
Contact: Ellen Sheets, MD, MBA 781-538-4737 esheets@csamedical.com
Contact: Ann Murphy-Legg, RN 781-538-4732 alegg@csamedical.com

Locations
Canada, British Columbia
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Angela Le    6048068931    ale@providencehealth.bc.ca   
Principal Investigator: Don Sin, MD         
Canada, Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada
Contact: Rosalie Labelle    6137378899 ext 75256    rolabelle@toh.ca   
Principal Investigator: Kayan Amjadi, MD         
Germany
Thoraxklinik-University Of Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Brigette Rump    49 6221 396 1212    Brigitte.Rump@med.uni-heidelberg.de   
Principal Investigator: Felix Herth, MD, PhD         
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Karin Klooster       k.klooster@umcg.nl   
Principal Investigator: Dirk-Jan Slebos         
United Kingdom
Chelsea and Westminster Hosptial/Royal Brompton Hosptial Recruiting
London, United Kingdom, SW10 9NH
Contact: Cielito Caneja       cielito.caneja@chelwest.nhs.uk   
Principal Investigator: Pallav Shah         
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Study Director: Ellen Sheets, MD, MBA CSA Medical
  More Information

Additional Information:
Publications:
Godwin BL, Coad JE, "Healing responses following cryothermic and hyperthermic tissue ablation. " SPIE Proceedings 2009: Volume 7181, p1-9
Pulmonary Physiology, Levitzky M. 7th ed. 2007, The McGraw-Hill Companies

Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT02483637     History of Changes
Other Study ID Numbers: 012
Study First Received: June 25, 2015
Last Updated: January 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by CSA Medical, Inc.:
spray cryotherapy
cryotherapy
chronic bronchitis
airflow restrictions

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on April 21, 2017