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Clinical Trials/NL-OMON42706
NL-OMON42706
Completed
Not Applicable

A Prospective Safety and Feasibility Study of the RejuvenAir* System Metered Cryospray Therapy for Chronic Bronchitis Patients. - Safety and Feasibility Study of RejuvenAir* for Treating Chronic Bronchitis

CSA MEDICAL, INC.0 sites15 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
CSA MEDICAL, INC.
Enrollment
15
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Males and females \>\=40 to \<\=75 years of age.
  • •Subject is able to read, understand, and sign a written Informed Consent.
  • •Subject agrees to continue maintenance pulmonary/COPD medications for the
  • •duration of the study.
  • •Diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease
  • •(COPD) for a minimum of two years. (Chronic Bronchitis is defined clinically as
  • •chronic productive cough for 3 months in each of 2 successive years in a patient in
  • •whom other causes of productive cough have been excluded.)
  • •Pre\-procedure post bronchodilator FEV1 of greater than or equal to 30% and less
  • •than or equal to 80% of predicted within 3 months of enrollment.

Exclusion Criteria

  • •Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks
  • •of study bronchoscopy.
  • •Subject has had a CB and/or COPD exacerbation (requiring steroids and/or
  • •antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their
  • •treating physician
  • •Subject has clinically significant bronchiectasis or other respiratory disease other
  • •than chronic bronchitis and COPD.
  • •Diagnosis of asthma with an onset before 30 years of age
  • •Subject has bullous emphysema characterized as large bullae \>30 millimeters on
  • •Subject has had a transplant.

Outcomes

Primary Outcomes

Not specified

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