Observational surveillance of Zephyr Valve use for severe emphysema in Japan

Zephyr Valve Japan Post-Marketing Surveillance

This study is testing the use of the Zephyr Valve in 140 patients with severe emphysema in Japan to see how it affects their lung function, exercise ability, and quality of life over a year.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pulmonx Corporation (industry)
• Locations: 17 sites (Aichi and 16 other locations)
• Trial ID: NCT06332885 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with severe emphysema who have completed recent respiratory rehabilitation and meet specific lung function criteria.

Not a fit: Patients with active respiratory infections or significant collateral ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve lung function and quality of life for patients with severe emphysema.

How similar studies have performed: Previous studies on bronchoscopic lung volume reduction have shown promising results, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Aichi and 16 other locations

• 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)
• Nagasaki University Hospital — Nagasaki, Japan (RECRUITING)
• Nagoya Medical Center — Nagoya, Japan (RECRUITING)
• Okayama Medical Center — Okayama, Japan (RECRUITING)
• Kinki Chuo Chest Medical Center — Osaka, Japan (RECRUITING)
• Hokkaido University Hospital — Sapporo, Japan (RECRUITING)
• Tohoku University Hospital — Sendai, Japan (RECRUITING)
• Shiga University Hospital — Shiga, Japan (RECRUITING)
• Tokyo National Hospital — Tokyo, Japan (RECRUITING)
• Fujita Health University Hospital — Toyoake, Japan (RECRUITING)
• Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) — Utsunomiya, Japan (NOT_YET_RECRUITING)
• Dokkyo University Hospital — Utsunomiya, Japan (RECRUITING)

Study contacts

• Study coordinator: Joshua Percy

Conditions: Emphysema, COPD, Severe Emphysema, Bronchoscopic lung volume reduction, Zephyr Valves