NCT02483637

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CSA Medical, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Bronchitis, Chronic
• Cryotherapy Effect

Interventions

Type	Name	Description
DEVICE	RejuvenAir	Device: RejuvenAir

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-05-01
• Completion: 2022-05-20
• First posted: 2015-06-29
• Last updated: 2023-02-23

Locations

3 sites across 3 countries: Canada, Netherlands, United Kingdom