This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung function and safety after treatment with OL-BF-001 for severe emphysema. OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit. A bronchial valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Subjects assigned to this study will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. The subjects will also receive medical management.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Toyoake, Aichi-ken, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kawasaki, Kanagawa, Japan
Unnamed facility
Matsusaka, Mie-ken, Japan
Unnamed facility
Mibu, Tochigi, Japan
Unnamed facility
Ube, Yamaguchi, Japan
Unnamed facility
Chiba, Japan
Unnamed facility
Fukuoka, Japan
Unnamed facility
Gifu, Japan
responder rate after deployment of valves
definition of responder: St. George's Respiratory Questionnaire (SGRQ) improving and Pulmonary Function improving (either Forced Expiratory Volume in 1 second (FEV1) improving or Inspiratory Capacity (IC) improving)
Time frame: 6months after deployment of valves
Change in exercise capacity as measured by Six Minute Walk Test (6MWT)
Time frame: before deployment of valves and 6months after deployment of valves
Change in dyspnea as measured by Baseline and Transition Dyspnea Indexes(BDI-TDI)
Time frame: before deployment of valves and 6months after deployment of valves
Change in health status as measured by St. George's Respiratory Questionnaire(SGRQ)
Time frame: before deployment of valves and 6months after deployment of valves
Change in dyspnea as measured by Medical Research Council, Modified (mMRC) Questionnaire
Time frame: before deployment of valves and 6months after deployment of valves
Change in pulmonary function as measured by FEV1,Forced Vital Capacity(FVC),Vital Capacity(VC),Residual Volume(RV),IC,Total Lung Capacity(TLC),RV/TLC,Diffusing Capacity of the Lung for Carbon Monoxide(DLCO)
Time frame: before deployment of valves and 6months after deployment of valves
Change in target lobe volume as measured by Quantitative CT (QCT)
Time frame: before deployment of valves and 6months after deployment of valves
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