CSP-00006: A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

About this Study

The purpose of this study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.

Sponsor Protocol ID:CSP-00006
IRB Number:2021V0781
Closed for Enrollment
Observational/Not Applicable
October 04, 2022
Eligibility Criteria
35 years old
Both Male and Female

Inclusion Criteria
  • At least 35 years of age
  • Has chronic bronchitis
  • Able to walk over 225 meters in 6 minutes
  • Receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilators with or without an inhaled corticosteroid for at least 8 weeks prior to randomization
  • Has cigarette smoking history of at least ten pack years and has stop smoking for a minimum of 6 months

Exclusion Criteria
  • Known unresolved lower respiratory tract infection
  • Has a steroid-dependent condition requiring greater than 10 mg of oral corticosteroid per day
  • Has any implantable electronic device, such as pacemaker
  • Has a history of arrhythmia within past two years
  • Has unresolved lung cancer
  • Has a pulmonary nodule or cavity that in the judgement of primary investigator may require intervention
  • Had prior lung surgery, such as lung transplant, LVRS, lobectomy, metal airway stent, valves, coils, or bullectomy
  • Has emphysema
  • Has actively smoked within the last 6 months
  • Has uncontrolled GERD
  • Has known severe pulmonary hypertension
  • Pregnant, nursing, or planning to get pregnant during study duration
  • Currently participating in another clinical study involving an investigational product

Categories Click category to view its trials.
Men's Health
Women's Health
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Thomas Hudson
Phone Number: 601-496-7808
Email: tmhudson@umc.edu
Principal Investigator:Senitko, Michal, M.D.
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