NCT06332885Recruiting
Zephyr Valve Japan Post-Marketing Surveillance
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 20 Mar 2024
- Start date
- Mar 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Pulmonx Corporation
- Diseases
- COPD
- NCT number
- NCT06332885
What you commit to
- Study type: Observational
- Planned participants: 140
- From Mar 2024 to the primary completion date, Mar 2027
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tosei General Hospital Coordinator of this site? Confirm its status | Aichi | Japan | Recruiting |
| Gifu Prefectural Medical Center Coordinator of this site? Confirm its status | Gifu | Japan | Recruiting |
| Kanagawa Cardio Chest Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Recruiting |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Recruiting |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| Matsusaka Civic Hospital Coordinator of this site? Confirm its status | Mie | Japan | Recruiting |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Recruiting |
| Nagoya Medical Center Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Kinki Chuo Chest Medical Center Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Shiga University Hospital Coordinator of this site? Confirm its status | Shiga | Japan | Recruiting |
| Tokyo National Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Recruiting |
| Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) Coordinator of this site? Confirm its status | Utsunomiya | Japan | Not yet recruiting |
| Dokkyo University Hospital Coordinator of this site? Confirm its status | Utsunomiya | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.