This is a prospective, multicenter, single arm and open-label clinical trial to evaluate the performance, effectiveness and safety of RheOx™ system in the treatment of the symptoms of chronic bronchitis in adult moderate to severe COPD patients.
Eligible patients will be assigned to two sessions of treatments with RheOx™ system. Treatment 1, named initial procedure is scheduled at right lung. And then treatment 2 is planned to treat left lung one month apart from initial procedure. Following-up post either RheOx procedure is scheduled at 2nd day discharged from hospital and day 14 (phone call) and 1 month. Patients will undergo follow-up evaluations at Month 3, 6 and 12 post-treatment 2. And a phone call is also scheduled every two months post treatment 2 except the above. The assessments will include quality of life questionnaires, pulmonary function testing, lung CT scan and monitoring any adverse events and also any changes in inhaled medication, unschedule clinic visit or ER visit and even hosptialization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Eligible patients be assigned two sessions of RheOx bronchial rheoplasty procedures * Treatment 1 is for the treatment of right lung * Treatment 2 is scheduled one month apart for left lung
Peking University First Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Xinqiao Hospital, Army Medical University
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Guangzhou Medical University
COPD Assessment Test (CAT) Score in Total
The mean change from baseline to Month 6. (The minimal is zero and maximal 40 points. The higher score means the impact is greater)
Time frame: 6 Month after second RheOx procedure (treatment 2 on left lung )
CAT Score in Total
The mean change from baseline to 3,12 months (The minimal is zero and maximal 40 points. The higher score means the impact is greater)
Time frame: 12 months
St. George's Respiratory Questionnaire (SGRQ)
The mean change of SGRQ total score from baseline to 3,6 and 12 months(The minimal is zero and maximal 100 points. The higher score means the impact is greater)
Time frame: 12 months
CAT response rate
At 3, 6 and 12 months after RheOx procedures
Time frame: 12 months
SGRQ response rate
At 3, 6 and 12 months after RheOx procedures
Time frame: 12 months
Distal airway volume
The mean change from baseline to Month 6 in distal airway volume (DAV) at expiration, as determined by an independent core lab
Time frame: Month 6
Total Airway Counts
The mean change from baseline to Month 6 in Total Airway Counts(TAC) as determined by an independent core lab
Time frame: Month 6
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Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Tenth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China