EmphysemaNCT06332885
Zephyr Valve Japan Post-Marketing Surveillance
An observational study of Emphysema and COPD, run by Pulmonx Corporation at 17 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema, COPD, Severe Emphysema
- What is being tested?
- Zephyr Endobronchial Valve
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 17 sitesJapan
- Study dates
- 12 Mar 2024to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The surveillance population will be adult patients (18 years or older) in Japan with hyperinflation of the lungs due to severe emphysema who are considered by their treating physician to be appropriate candidates for BLVR using Zephyr Valve and confirmed to have little to no collateral ventilation (CV-) in the target lobe. The surveillance will enroll all patients treated at the participating hospitals who provide written informed consent.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Japan17 sites, 17 recruiting
- Recruiting
Tosei General Hospital
Aichi
Kensuke Kataoka, MD, +81 561-82-5101, kataoka@tosei.or.jp
Kensuke Kataoka, MD
- Recruiting
Gifu Prefectural Medical Center
Gifu
Takahiro Masami, chiken-center.4289@gifu-hp.jp
Fumihiro Asano, MD, PhD
- Recruiting
Kanagawa Cardio Chest Center
Kanagawa
Takashi Niwa, MD, wanikko0714@gmail.com
Takashi Niwa, MD
- Recruiting
Kanazawa University Hospital
Kanazawa
Satoshi Watanabe, MD, swatanabe@staff.kanazawa-u.ac.jp
Satoshi Watanabe, MD
- Recruiting
St Marianna University Hospital
Kawasaki
Masamichi Mineshita, MD, m-mine@marianna-u.ac.jp
Masamichi Mineshita, MD
- Recruiting
Matsusaka Civic Hospital
Mie
Osamu Hataji, MD, +81 598-23-1515, mch1031@city-hosp.matsusaka.mie.jp
Osamu Hataji, MD
- Recruiting
Nagasaki University Hospital
Nagasaki
Keitaro Matsumoto, MD, kmatsumo@nagasaki-u.ac.jp
Keitaro Matsumoto, MD
- Recruiting
Nagoya Medical Center
Nagoya
Masahide Oki, MD, masahideo@gmail.com
Masahide Oki, MD
- Recruiting
Okayama Medical Center
Okayama
Yanagihara, okmc-iec@nifty.com
Ken Sato, MD
- Recruiting
Kinki Chuo Chest Medical Center
Osaka
Akihiro Tamiya, MD, tamiya.akihiro.tz@mail.hosp.go.jp
Akihiro Tamiya, MD
- Recruiting
Hokkaido University Hospital
Sapporo
Naofumi Shinagawa, MD, naop.shinagawa@nifty.ne.jp
Naofumi Shinagawa, MD
- Recruiting
Tohoku University Hospital
Sendai
Hirotsugu Notsuda, MD, hirotsugu.notsuda.c4@tohoku.ac.jp
Hirotsugu Notsuda, MD
- Recruiting
Shiga University Hospital
Shiga
Yasuki Uchida, MD, uchiy@belle.shiga-med.ac.jp
Yasuki Uchida, MD
- Recruiting
Tokyo National Hospital
Tokyo
Hiroyuki Tashimo, MD
Hiroyuki Tashimo, MD
- Recruiting
Fujita Health University Hospital
Toyoake
Risako Koshiyama, gcpjim@fujita-hu.ac.jp
Kazuyoshi Imaizumi, MD
- Not yet recruiting
Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)
Utsunomiya
Yasuo Shimizu, MD, yasuo-s@dokkyomed.ac.jp
Yasuo Shimizu, MD
- Recruiting
Dokkyo University Hospital
Utsunomiya
Masayuki Chida, MD, chidaths@dokkyomed.ac.jp
Masayuki Chida, MD
About this study
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.
Read the detailed description
This is a multicenter, prospective, observational surveillance across 20 centers in Japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for BLVR using Zephyr Endobronchial Valve (EBV, Pulmonx Corporation) and confirmed to have little to no collateral ventilation in the target lobe.
Enrolled (consented) subjects will undergo a bronchoscopy procedure with the Chartis assessment to confirm that little to no collateral ventilation is present (CV- status) followed by EBV placement in the most diseased lobe. Subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months.
Subjects with collateral ventilation will be exited from the surveillance without treatment.
The primary endpoint is incidence rate of pneumothorax at Day 45 post-index procedure.
The effectiveness will be evaluated from Baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. A high-resolution computed tomography (HRCT) will be performed at Day 45 and Month 12 to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed at Month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6 Minutes Walking Distance. The safety will be evaluated based on incident rate of treatment emergent adverse events through Month 12.
Subjects will be required to complete a pulmonary rehabilitation program between Day 45 and Month 3 per local/national guidelines.
- Conditions
- Emphysema, COPD, Severe Emphysema
- Being tested
- Zephyr Endobronchial Valve
- Keywords
- Bronchoscopic lung volume reduction, Zephyr Valves
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zephyr Endobronchial ValveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Bronchoscopic lung volume reduction with Zephyr Valves Receives: Device: Zephyr Endobronchial Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.
Measured: 45-days post-Zephyr Valve index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start12 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Narinder Shargill, PhD, Study director, Pulmonx Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332885
- Sponsor's protocol ID
- 630-2001-01
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will be aggregated and analyzed. No IPD will be made available for sharing to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zephyr Valve Japan Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT06332885
- Acronym / sponsor ID
- 630-2001-01
- Conditions
- Emphysema, COPD, Severe Emphysema
- Keywords
- Bronchoscopic lung volume reduction, Zephyr Valves
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, prospective, observational surveillance across 20 centers in Japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for BLVR using Zephyr Endobronchial Valve (EBV, Pulmonx Corporation) and confirmed to have little to no collateral ventilation in the target lobe.
Enrolled (consented) subjects will undergo a bronchoscopy procedure with the Chartis assessment to confirm that little to no collateral ventilation is present (CV- status) followed by EBV placement in the most diseased lobe. Subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months.
Subjects with collateral ventilation will be exited from the surveillance without treatment.
The primary endpoint is incidence rate of pneumothorax at Day 45 post-index procedure.
The effectiveness will be evaluated from Baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. A high-resolution computed tomography (HRCT) will be performed at Day 45 and Month 12 to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed at Month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6 Minutes Walking Distance. The safety will be evaluated based on incident rate of treatment emergent adverse events through Month 12.
Subjects will be required to complete a pulmonary rehabilitation program between Day 45 and Month 3 per local/national guidelines.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | Device: Zephyr Endobronchial ValveBronchoscopic lung volume reduction with Zephyr Valves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The surveillance population will be adult patients (18 years or older) in Japan with hyperinflation of the lungs due to severe emphysema who are considered by their treating physician to be appropriate candidates for BLVR using Zephyr Valve and confirmed to have little to no collateral ventilation (CV-) in the target lobe. The surveillance will enroll all patients treated at the participating hospitals who provide written informed consent.
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zephyr Endobronchial ValveZephyr 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. | Device | Single Group Assignment |
Primary outcome
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
Time frame: 45-days post-Zephyr Valve index procedure
The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. All data will be aggregated and analyzed. No IPD will be made available for sharing to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Narinder Shargill, PhD study director
Pulmonx Corporation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema and COPD, run by Pulmonx Corporation at 17 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Barrigar (+1 650-216-0128, marie.barrigar@pulmonx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure. (time frame: 45-days post-Zephyr Valve index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.