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A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

This study is evaluating an investigational metered cryospray treatment and how well it reduces symptoms of COPD with chronic bronchitis. The study is called SPRAYCB and it uses an investigational device called RejuvenAir.®

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Study Type/Phase: Interventional
Enrollment Status: Recruiting

This study is evaluating an investigational treatment and how well it reduces the symptoms of chronic bronchitis, like cough and phlegm. The study treatment is called Metered Cryospray and uses an investigational device called RejuvenAir®.

This study requires:

  • Up to 15 visits/assessments with study team (up to 14 in-person and 1 remote)
  • Undergo bronchoscopy procedures
  • Blood collection
  • Vital signs
  • CT imaging scans
  • Lung function tests
  • Completing questionnaires
  • Periodic Cough Monitoring

Who can participate?

  • Ages 40 to 80 years old
  • Has chronic bronchitis
  • Receiving standard medications for bronchitis
  • Have not smoked in at least 6 months
  • Not pregnant or breastfeeding

 

Principal Investigator

Ganesh Krishna, MD

Sponsor

CSA Medical, Inc.

NCT Number

NCT03893370

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.