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

Cryotherapy Effect Clinical Trial

Official title:
A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients

Clinical Trial Summary

This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02483637
Study type Interventional
Source CSA Medical, Inc.
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date May 20, 2022
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