No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
140 (estimated)
Sponsor
Pulmonx Corporation · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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 active…
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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