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New lung valve registry aims to improve breathing in severe emphysema

NCT ID NCT04302272

Symptom relief Sponsor: Olympus Corporation of the Americas 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This registry study is tracking 150 adults with severe emphysema who receive the Spiration Valve System, a one-way valve placed in the lung via a bronchoscope. The goal is to see if the device safely reduces shortness of breath and lung overinflation over 12 to 36 months. Participants must have low collateral ventilation to be eligible.

What this could mean

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

Active substance
Spiration Valve System (a one-way endobronchial valve device)
What this could lead to
If successful, this could confirm that the Spiration Valve System is a safe and effective option to ease shortness of breath and lung overinflation in severe emphysema patients.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. Risks include pneumothorax (collapsed lung) and other serious lung events.

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

Oct 2021

Expected to finish

Oct 2029

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

Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.

Ages

18 years and older

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: 1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation. 2. Subjects must understand and voluntarily sign an informed consent form. Exclusion Criteria: 1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements. 2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3. Subjects who have incomplete screening or baseline data.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease pulmonary emphysema

As listed by the trial registrant

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

Emphysema

How to take part

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

  1. The places running it

    16 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

  • AnMed Health

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75204, United States

  • Beth Israel Decaconess

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dignity Health St. Joseph's Hospital and Medical Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • El Camino, Taft Center for Clinical Research

    RECRUITING

    Mountain View, California, 94040, United States

  • LSU Health Shreveport

    RECRUITING

    Shreveport, Louisiana, 71130, United States

  • Memorial Hospital at Gulfport

    RECRUITING

    Gulfport, Mississippi, 39501, United States

  • Northwestern University, Division of Pulmonary and Critical Care Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Penn State Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • University of Texas Health Science Center at Houston

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

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