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One-Way valves in the lung: can they help emphysema patients breathe easier?

NCT ID NCT04186546

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

This registry follows people with severe emphysema who receive Zephyr endobronchial valves, tiny one-way valves placed in the diseased parts of the lung during a bronchoscopy. Blocking airflow to damaged regions may let healthier lung tissue expand and work better. Researchers track safety problems such as collapsed lung, bleeding, and infection, and measure how much the treated lung region shrinks. The study enrolls about 150 participants whose doctors consider them suitable for 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 valves, small one-way valves placed in the lung during a bronchoscopy procedure
What this could lead to
If the valves perform well outside controlled studies, doctors could gain clearer guidance on which emphysema patients benefit most and what risks to expect.
What could go wrong
The registry observes real-world use rather than testing the device against a comparison group, so it cannot prove the valves cause any improvement. Known risks include collapsed lung, bleeding, infection, and valve movement.
Why investors are watching

Pulmonx sells the Zephyr Valve, and this post-approval registry collects real-world safety and effectiveness data on the treatment in 150 participants. For a small company whose revenue depends on this single device, registry results can support continued use and payer coverage. The registry does not test a new therapy, so it measures how the device performs outside controlled studies.

If it works: Positive registry data may reassure doctors and payers, which can support wider use of the Zephyr Valve. That could help Pulmonx grow sales without running a new pivotal trial.

If it fails: If the registry shows safety or effectiveness problems, regulators and payers may restrict use of the device. Registries can also take years to complete, and slow enrollment or delayed results would leave the company without the real-world evidence it needs.

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 150 people

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

Started

Nov 2019

Expected to finish

Dec 2026

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 Registry population will be comprised of subjects with hyperinflation of the lungs due to severe emphysema that are prescribed the Zephyr Valve treatment by their physician and confirmed to have little to no collateral ventilation.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Subjects with severe emphysema considered appropriate for the procedure by the physician. * Subjects who signed an Informed Consent Form to allow data collection. Exclusion Criteria: • Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).

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Conditions

The condition(s) this trial relates to.

pulmonary emphysema

As listed by the trial registrant

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

Emphysema

Contacts and locations

Locations

  • Froedtert Memorial-Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Inova Health

    Fairfax, Virginia, 22031, United States

  • Northwestern Medicine

    Winfield, Illinois, 60190, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The Lung Center

    DuBois, Pennsylvania, 15801, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15123, United States

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