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Zephyr Valve Japan Post-Marketing Surveillance

Recruitingn/aAges 18 Years - anyAllPulmonx Corporation
NCT06332885 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include: * Recent respiratory rehabilitation completed within the last 6 months * Not actively smoking (for at least 4 months) * TLC ≥ 100% * RV ≥ 175% * FEV1 15-45% post-bronchodilator * 6MWD 100-500 m * mMRC score ≥ 2 * No coagulation disorder * No evidence of active respiratory infection 2. Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR. 3. Patient is willing and able to provide informed consent to allow data collection. Exclusion Criteria: None
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What it tests

  • Zephyr Endobronchial Valve
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Where

17 sites
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

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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