Observational surveillance of Zephyr Valve use for severe emphysema in Japan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational surveillance study aims to enroll 140 patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using the Zephyr Endobronchial Valve across 20 centers in Japan. Participants will undergo a bronchoscopy procedure to confirm the absence of collateral ventilation before receiving the valve placement. The study will follow patients for 12 months to assess lung function, exercise capacity, and quality of life, with a primary focus on the incidence of pneumothorax post-procedure. High-resolution CT scans will be performed to evaluate lung volume reduction at specified time points.

Why it matters

Who can join: the full rules

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

Where it's running

• Tosei General Hospital
  Aichi, Japan Recruiting
• Gifu Prefectural Medical Center
  Gifu, Japan Recruiting
• Kanagawa Cardio Chest Center
  Kanagawa, Japan Recruiting
• Kanazawa University Hospital
  Kanazawa, Japan Recruiting
• St Marianna University Hospital
  Kawasaki, Japan Recruiting
• Matsusaka Civic Hospital
  Mie, Japan Recruiting

Study contacts

• Study coordinator: Marie Barrigar
• Email: marie.barrigar@pulmonx.com
• Phone: +1 650-216-0128

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.