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Zephyr Valve Japan Post-Marketing Surveillance
Sponsor: Pulmonx Corporation
Summary
This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
140
Start Date
2024-03-12
Completion Date
2028-03-31
Last Updated
2024-12-13
Healthy Volunteers
No
Conditions
Interventions
Zephyr Endobronchial Valve
Zephyr Valve provides an alternative technique to achieve bronchoscopic lung volume reduction (BLVR) using a minimally invasive approach. Zephyr Valve is a tiny unidirectional valve. During BLVR, multiple valves are placed to occlude a hyperinflated lobe of the lungs, allowing air to escape while blocking airflow into the treated lobe. This is intended to result in a reduction in lung volume and hyperinflation in the targeted area. Consequently, the remaining lobes can expand more fully, the overall lung works more efficiently, with resultant improvement in overall lung function in patients with hyperinflation associated with severe emphysema.
Locations (17)
Tosei General Hospital
Aichi, Japan
Gifu Prefectural Medical Center
Gifu, Japan
Kanagawa Cardio Chest Center
Kanagawa, Japan
Kanazawa University Hospital
Kanazawa, Japan
St Marianna University Hospital
Kawasaki, Japan
Matsusaka Civic Hospital
Mie, Japan
Nagasaki University Hospital
Nagasaki, Japan
Nagoya Medical Center
Nagoya, Japan
Okayama Medical Center
Okayama, Japan
Kinki Chuo Chest Medical Center
Osaka, Japan
Hokkaido University Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
Shiga University Hospital
Shiga, Japan
Tokyo National Hospital
Tokyo, Japan
Fujita Health University Hospital
Toyoake, Japan
Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)
Utsunomiya, Japan
Dokkyo University Hospital
Utsunomiya, Japan