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Tiny One-Way valves for emphysema under close watch in japan

NCT ID NCT06332885

Symptom relief Sponsor: Pulmonx Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers in Japan are observing 140 people with severe emphysema who receive Zephyr Endobronchial Valves, tiny one-way valves placed in the lungs to reduce hyperinflation. The surveillance follows participants for 12 months across up to 20 centers. The main goal is to measure how often pneumothorax, a collapsed lung, occurs within 45 days after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zephyr Endobronchial Valve, a tiny one-way valve placed in the lung airways to reduce hyperinflation
What this could lead to
If the surveillance supports the valve's safety profile, it could strengthen the case for bronchoscopic lung volume reduction as a less invasive option for people with severe emphysema.
What could go wrong
This is an observational study, not a randomized trial, so it cannot prove the valve works better than other treatments. The main risk being tracked is pneumothorax, a collapsed lung, which can occur after the procedure.
Why investors are watching

Pulmonx sells the Zephyr Endobronchial Valve, and this post-marketing surveillance tracks 140 patients with severe emphysema at up to 20 centers in Japan for 12 months. The study measures symptom relief in real-world use, so its results shape how Japanese doctors adopt the device and how the company's smallest major market grows.

If it works: Positive symptom results could support wider use of the Zephyr valve in Japan and strengthen Pulmonx's case with physicians and regulators there.

If it fails: Weak symptom results or slow enrollment could limit adoption in Japan and leave the company with fewer markets carrying its growth. Surveillance studies often produce mixed results, and this one has no stated phase or control group.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset pulmonary emphysema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD Emphysema Severe emphysema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dokkyo University Hospital

    RECRUITING

    Utsunomiya, Japan

  • Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)

    NOT_YET_RECRUITING

    Utsunomiya, Japan

  • Fujita Health University Hospital

    RECRUITING

    Toyoake, Japan

  • Gifu Prefectural Medical Center

    RECRUITING

    Gifu, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Japan

  • Kanagawa Cardio Chest Center

    RECRUITING

    Kanagawa, Japan

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, Japan

  • Kinki Chuo Chest Medical Center

    RECRUITING

    Osaka, Japan

  • Matsusaka Civic Hospital

    RECRUITING

    Mie, Japan

  • Nagasaki University Hospital

    RECRUITING

    Nagasaki, Japan

  • Nagoya Medical Center

    RECRUITING

    Nagoya, Japan

  • Okayama Medical Center

    RECRUITING

    Okayama, Japan

  • Shiga University Hospital

    RECRUITING

    Shiga, Japan

  • St Marianna University Hospital

    RECRUITING

    Kawasaki, Japan

  • Tohoku University Hospital

    RECRUITING

    Sendai, Japan

  • Tokyo National Hospital

    RECRUITING

    Tokyo, Japan

  • Tosei General Hospital

    RECRUITING

    Aichi, Japan

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