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New Two-Step valve procedure aims to cut lung collapse risk in emphysema patients

NCT ID NCT06181357

Disease control Sponsor: University Hospital, Limoges 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of placing Zephyr valves in the lungs of people with severe emphysema (a type of COPD). The standard method treats the entire lobe in one session, but about 27% of patients develop a collapsed lung (pneumothorax). The experimental method spreads the valve placement over two sessions, which early studies suggest may lower that risk to between 4.5% and 12%. The trial will enroll 244 adults aged 35–80 with severe emphysema who have quit smoking, and will track pneumothorax rates and lung function over 45 days.

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
What this could lead to
If successful, this two-stage procedure could lower the risk of lung collapse (pneumothorax) after valve placement, making treatment safer for people with severe emphysema.
What could go wrong
This is a relatively small trial (244 people) and has not yet been compared directly to the standard method. The two-stage approach requires two procedures, which may still carry risks and might not prove superior.

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 244 people

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

Started

May 2024

Expected to finish

Jun 2029

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

35 to 80 years

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: Patient able to give informed consent and participate in the study * Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent * Emphysema (homogeneous or heterogeneous) on a recent CT scan (\< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes. * Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner * Smoking quit for 3 months * Dyspnea ≥ 2 according to the modified Medical Research Council (mMRC) questionnaire) * Post-bronchodilator FEV between 15 and 50% theoretical * Post-bronchodilator total lung capacity ≥ 100% theoretical and post-bronchodilator residual volume ≥ 175% theoretical * Distance traveled during the TM6M ≥ 100m * Member of or beneficiary of a social security scheme Exclusion Criteria: * Asthma considered as main diagnosis * Recurrent exacerbations: (\>3 over the last year or 2 requiring hospitalization) * Myocardial infarction or stroke in the 6 months prior to inclusion * Symptoms of heart failure in the 6 months prior to inclusion * Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi * Pulmonary tomoscintigraphy: * Patients for whom the least perfused lobe is not the one with the highest emphysema destruction score * Patients with homogeneous emphysema for whom the perfusion delta (difference in perfusion between the ipsilateral lung and the treated lobe) is less than 10% * Arterial blood gas analysis in ambient air: Hypoxemia in ambient air (PaO2 \< 45 mmHg). Hypercapnia (PaCO2 \> 55 mmHg) * Echocardiography: * Left Ventricular Ejection Function \< 45% * Systolic pulmonary arterial pressure \> 45 mmHg * History of pneumonectomy, lung surgery homolateral to the lobe targeted for endoscopic lung volume reduction * History of pneumothorax homolateral to the lobe targeted for endoscopic lung volume reduction * History of endoscopic volume reduction * Oral corticosteroid therapy \> 20 mg/day within the 4 weeks preceding inclusion * Symptomatic bronchial dilatations, bronchial colonization with pseudomonas aeruginosa, multi-resistant bacteria or aspergillus origin * Metastatic cancer undergoing treatment or whose treatments ended less than 5 years ago * Pregnant or breastfeeding women * Nickel allergy * Patient under guardianship, curatorship or under judicial protection * Participation in another interventional clinical research * Any other condition which, in the opinion of the investigator, could interfere with the objective of the study or would cause the subject's participation in the study to be suboptimal, in particular (non-exhaustive list) unweaned alcoholism, substance abuse, non-compliance with usual follow-up visits) secondary exclusion criteria: \- Evidence of collateral ventilation measured by the Chartis system

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset pneumothorax pulmonary emphysema

As listed by the trial registrant

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

COPD

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

  • APHM

    RECRUITING

    Marseille, 13000, France

  • APHP

    RECRUITING

    Paris, 75018, France

  • APHP

    NOT_YET_RECRUITING

    Paris, 78014, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • CHU de Brest

    RECRUITING

    Brest, 29000, France

  • CHU de Dijon

    RECRUITING

    Dijon, 21000, France

  • CHU de Lille

    RECRUITING

    Lille, 59000, France

  • CHU de Limoges

    RECRUITING

    Limoges, 87000, France

  • CHU de Nice

    NOT_YET_RECRUITING

    Nice, 06000, France

  • CHU de Rouen

    NOT_YET_RECRUITING

    Rouen, 76000, France

  • Groupe Hospitalier Est - HCL

    NOT_YET_RECRUITING

    Bron, 69500, France

  • Hopital Foch

    RECRUITING

    Suresnes, 92150, France

  • Hopital Saint Joseph

    RECRUITING

    Marseille, 13000, France

  • Hopital privé de la loire

    RECRUITING

    Saint-Etienne, 42000, France

  • chu de Grenoble

    RECRUITING

    Grenoble, 38000, France

  • chu de Strasbourg

    RECRUITING

    Strasbourg, 67000, France

  • chu de Toulouse

    RECRUITING

    Toulouse, 31000, France

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