Zephyr Valve Japan Post-Marketing Surveillance
Pulmonx Corporation
140 participants
Mar 12, 2024
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
Inclusion Criteria12
- 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
- MWD 100-500 m
- mMRC score ≥ 2
- No coagulation disorder
- No evidence of active respiratory infection
- Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
- Patient is willing and able to provide informed consent to allow data collection.
Interventions
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)
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NCT06332885