Clinical Trial: Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
Brief Summary: This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.
Detailed Summary: 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.
Sponsor: CSA Medical, Inc.
Current Primary Outcome: Adverse and Serious Adverse Events [ Time Frame: 60 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: CSA Medical, Inc.
Dates:
Date Received: June 25, 2015
Date Started: February 2016
Date Completion: September 2019
Last Updated: May 10, 2017
Last Verified: May 2017
