RejuvenAir™ System Chronic Bronchitis Version 2
A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
CSA Medical, Inc.
Duration of Study in the UK
4 years, 0 months, 1 days
Phase A will enroll 12 subjects and treat a single lobe to assess safety, feasibility and histology/immunology. After review by the Data Safety Monitoring Board, Phase B of the study will commence.
Phase A subjects will have treatment of the right lower lobe and right main stem. Up to six biopsies and photographic documentation of biopsy sites will be collected.
Bronchial wall brushings and a bronchial wall wash will preceed treatment of metered cryospray (MCS). Each MCS is tailored to the bronchial area undergoing treatment. Repeat biopsies, brushings and washes will be performed in the same area at 60 +/- 7 days post-therapy completion.
Phase B of the study will treat the left lower lobe and associated left main stem of Phase A subjects followed 30 to 45 days later by a third treatment to both upper lobes, and any untreated main stem bronchus and base of trachea. Prior to treatment each subject will have bronchial wall brushings and bronchial washes. An additional 24 subjects will be recruited in Phase B and have 3 treatments of the same areas as Phase A.
All subjects will be assessed for visual evidence of chronic bronchitis in their airways during every bronchoscopic procedure and a video will be recorded of the procedure. Additionally all subjects will be asked to complete patient reported outcomes (PRO) questionnaires as well as undergo pre- and post-treatment FEV1, FEV1/FVC, VC, FIV1, RAW, plasma fibrinogen, HRCT and 6MWT (six minute walk test) at specific intervals.
Subjects will be followed at months 3, 6, 9, 12, 24, and 36 months for a total study duration of 3 years.
London - Stanmore Research Ethics Committee
Date of REC Opinion
6 Nov 2015
Further Information Favourable Opinion