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Lung valve aims to release trapped air in severe emphysema

NCT ID NCT07097896

Disease control Sponsor: China-Japan Friendship Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests a silicone valve placed in the airways to reduce overinflated parts of the lung in people with severe emphysema. The valve lets trapped air escape, which may improve breathing and daily function. Participants receive either the valve plus standard care or standard care alone. The study measures changes in lung function and quality of life over one year.

What this could mean

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

Active substance
endobronchial silicone valve
What this could lead to
If it works, this could offer a new, less invasive option to improve breathing and quality of life for people with severe emphysema.
What could go wrong
This is a relatively small trial, and the valve may not work for everyone. Risks include infection, valve movement, or worsening breathing.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 147 people

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

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Clinical and radiological evidence of emphysema * Nonsmoking for 4 months prior to screening interview * BMI less than 35 kg/m2 * Stable on current medication regimen * Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value * Residual Volume less than 175% predicted (determined by body plethysmography) * Little or no collateral ventilation (CV-) as determined using the Chartis System Exclusion Criteria: * Had two or more hospitalizations over the last year for a COPD exacerbation * Had two or more hospitalizations over the last year for pneumonia * Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy * Had a heart attack or congestive heart failure within the last 6 months * Have heart arrhythmia * Is alpha-1 antitrypsin deficient

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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

    1 site. 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

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

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