NCT06332885 Zephyr Valve Japan Post-Marketing Surveillance
| NCT ID | NCT06332885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pulmonx Corporation |
| Condition | Emphysema |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2024-03-12 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ryan Melloy, MBA
STUDY DIRECTOR
Pulmonx Corporation
Frequently Asked Questions
Who can join the NCT06332885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Emphysema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06332885 currently recruiting?
Yes, NCT06332885 is actively recruiting participants. Contact the research team at jpercy@pulmonx.com for enrollment information.
Where is the NCT06332885 trial being conducted?
This trial is being conducted at Aichi, Japan, Gifu, Japan, Kanagawa, Japan, Kanazawa, Japan and 11 additional locations.
Who is sponsoring the NCT06332885 clinical trial?
NCT06332885 is sponsored by Pulmonx Corporation. The principal investigator is Ryan Melloy, MBA at Pulmonx Corporation. The trial plans to enroll 140 participants.