RecruitingNCT06332885

Zephyr Valve Japan Post-Marketing Surveillance


Sponsor

Pulmonx Corporation

Enrollment

140 participants

Start Date

Mar 12, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a post-marketing surveillance program in Japan monitoring the real-world use of the Zephyr Endobronchial Valve — a small one-way valve placed in the airways of people with severe emphysema (a form of advanced COPD — a chronic lung condition that makes breathing very difficult). The valve reduces hyperinflation in the most damaged part of the lung, allowing healthier parts to work better. This study collects safety and effectiveness data from patients in routine clinical practice. **You may be eligible if:** - Your doctor has determined that you are a suitable candidate for this valve procedure, based on Japanese medical guidelines - You recently completed pulmonary rehabilitation (within the past 6 months) - You stopped smoking at least 4 months ago - Your lung function tests meet the required thresholds - You can walk between 100 and 500 meters in a 6-minute walk test - Your breathlessness is significantly impacting daily life - Testing (Chartis system) shows the targeted lung lobe has little to no air leaking between lobes (collateral ventilation) **You may NOT be eligible if:** - There are no specific exclusion criteria listed — eligibility is based on your doctor's assessment and adherence to approved guidelines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZephyr 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

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NCT06332885


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