Foam plug could open door to lung valve therapy for thousands

NCT ID NCT06035120

Disease control Sponsor: Pulmonx Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests a foam called AeriSeal that is squirted into damaged parts of the lung to block tiny air leaks. After the foam, doctors check if the lung is now sealed enough to place a one-way valve that lets trapped air escape. The goal is to help people with severe emphysema breathe easier. About 200 participants will be followed for two years.

What this could mean

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

Active substance: AeriSeal Foam (a foam delivered via bronchoscope to block collateral ventilation in the lung)
What this could lead to: If it works, this could allow more people with severe emphysema to get lung volume reduction with valves, improving breathing and quality of life.
What could go wrong: This is an early-stage, single-arm study with no placebo group, so results may not be definitive. The foam and valve procedure carry risks like infection, air leaks, or worsening breathing.

Why investors are watching

Pulmonx is testing whether its AeriSeal foam can convert patients with collateral ventilation to a status that allows treatment with its Zephyr valve, expanding the pool of emphysema patients eligible for its products. For a small company, this trial's outcome directly affects how many patients can use its technology and whether its product line works as a combined system.

If it works: If the trial succeeds, Pulmonx could offer a two-step treatment that reaches more emphysema patients, potentially broadening its market and strengthening its product portfolio.

If it fails: If the trial fails or enrollment stalls, Pulmonx may face delays in expanding its addressable patient group, and the company's prospects could weaken. Clinical trials often fail, so a negative result is a real possibility.

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.

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 200 people

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

Started

Feb 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.

Ages

40 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: 1. Subject is willing and able to provide informed consent and to participate in the study. 2. Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date. 3. Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline. 4. Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels. 5. Subject has a recent HRCT meeting the scan parameter requirements and performed within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units: 1. At least one (1) lobe with segmental emphysema destruction score ≥ 50%. 2. Subject has heterogenous emphysema, defined as difference in emphysema destruction score of ≥ 15 between the density scores of the target lobe and the ipsilateral non-target lobe(s) per QCT report with % voxel density of \< -910 HU. For non-target lobes that include the RML, calculate the combination of non-target lobes as a single density score using volume-weighted percent. 3. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention. 4. Subject has a gap in the interlobar fissure that corresponds to one or more segments and the fissure(s) contacting the target lobe is ≥ 80% complete per QCT report. 5. Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR). 6. Subject has 6MWD ≥ 150 m and ≤ 450 m. 7. Subject has clinically significant dyspnea with an mMRC score of ≥ 2. 8. Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted. 9. Subject has an FEV1/FVC ratio of \< 0.7. 10. Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted. 11. Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography. 12. Subject has post-bronchodilation DLCO ≥ 20% predicted. 13. Subject has received preventative vaccinations against potential respiratory infections, including COVID-19, consistent with local recommendation or policy. 14. Subject is on optimal medical management for more than one month prior to the ICF signature date. 15. Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the AeriSeal Index Procedure. Exclusion Criteria: 1. Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of any type, except BLVR using Zephyr Valve with \< 50% TLVR at 6 months, followed by valve removal \> 6 months prior to ICF signature date. 2. Subject has visible radiological abnormality on HRCT scan such as pulmonary nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years or more without increase in size or if deemed benign by biopsy) or active pulmonary infection (e.g., unexplained parenchymal infiltrate, significant interstitial lung disease or significant pleural disease). 3. Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms. 4. Large bullae encompassing greater than 1/3 of the total lung. 5. Subject had 3 or more COPD exacerbations requiring hospitalization within 12 months preceding the ICF signature date or a COPD exacerbation requiring hospitalization within 8 weeks of the ICF signature date. Subjects may be re-considered for future enrollment. 6. Subject has asthma as their primary diagnosis. 7. Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis. 8. Subject has clinically significant bronchiectasis. 9. Subjects with evidence of active respiratory infection should be considered for enrollment only after satisfactory resolution. 10. Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleep apnea is permitted. 11. Subject has severe gas exchange abnormalities as defined by any one of the following tests, conducted at rest, on room air, as tolerated. * PaCO2 ≥ 50 mm Hg (6.7 kPa) * PaO2 \< 45 mm Hg (6.0 kPa) 12. Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure \> 45 mm Hg. 13. Subject has known documented alpha-1 antitrypsin deficiency. 14. Subject has clinically significant hematological disorder. 15. Subject has recent significant unplanned or unexplained weight loss or other relevant comorbidities considered by the investigator to be potentially confounding or limiting to the subject's participation in the study. 16. Subject has non-atrial arrhythmias or conduction abnormalities on EKG. 17. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines (Fleisher 2007) or has ischemic heart disease, congestive heart failure, cerebrovascular disease (stroke or TIA within 6 months of the ICF signature date), serum creatinine \> 2.0 mg/dL (177 μmol/L), or left ventricular ejection fraction (LVEF) \< 45% on echocardiogram. 18. Subject has uncontrolled exercise induced syncope. 19. Subject has evidence of severe disease which in the judgment of the investigator may compromise the anticipated treatment effect or the subject's survival for the duration of at least 12 months. 20. Subject has any other condition that the investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject including but not limited to alcoholism, high risk for drug abuse, or noncompliance in returning for follow-up visits. 21. Subject cannot tolerate corticosteroids or relevant antibiotics. 22. Subject use of systemic corticosteroids \> 20 mg/day prednisolone or equivalent within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment. 23. Subject use of immunosuppressive agents within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment. 24. Subject is unable to temporarily discontinue heparins and oral anticoagulants (e.g., warfarin, dicumarol) according to local pre-procedural protocols. Note: Antiplatelet drugs including aspirin, thienopyridines and ticagrelor are permitted. 25. Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia. 26. Subject has known allergy to the following device components: Polyether block amide (PEBAX), Polyvinyl Alcohol or Glutaraldehyde, Nitinol (nickel-titanium) or its constituent metals (nickel or titanium) or Silicone. 27. Subject is a female who is pregnant (positive βHCG Pregnancy test), breast-feeding, or planning to be pregnant in the next 12 months. 28. Subject has Body Mass Index \< 18 kg/m2 or \> 35 kg/m2. 29. Subject participated in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the ICF signature date. Note: Subjects being followed as part of a long-term surveillance of a non-pulmonary study that has reached its primary endpoint are eligible for participation in this study.

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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 or COPD Emphysema, pulmonary

How to take part

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

The places running it

35 sites in 9 countries. The list below names each one and where it is.
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 ↗
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

ASST Spedali Civili, University Hospital
RECRUITING

Brescia, Italy, Italy
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Asklepios Klinik Barmbek
RECRUITING

Hamburg, Germany, Germany
Banner University Medical Center
RECRUITING

Phoenix, Arizona, 85006, United States
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02115, United States
Brigham Lung Center
WITHDRAWN

Boston, Massachusetts, 02115, United States
CHRU Strasbourg
RECRUITING

Strasbourg, France, France
CHU Limoges
RECRUITING

Limoges, France, France
CHU Toulouse
RECRUITING

Toulouse, France, France
Cleveland VA Northeast
WITHDRAWN

Cleveland, Ohio, 44106, United States
Fort Sanders Regional Medical Center (StatCare)
RECRUITING

Knoxville, Tennessee, 37916, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Hopital Bichat-APHP
RECRUITING

Paris, France, France
Hospital Universitario y Politecnico La Fe
RECRUITING

Valencia, Spain, Spain
Inova Fairfax Hospital
RECRUITING

Falls Church, Virginia, 22042, United States
Klinik Floridsdorf
RECRUITING

Vienna, Austria, Austria
Lungenklinik Hemer
RECRUITING

Hemer, Germany, Germany
Macquarie University
RECRUITING

Macquarie Park, Australia, Australia
Medical College of Wisconsin (MCW)
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
OSF Saint Francis Medical Center
RECRUITING

Peoria, Illinois, 61606, United States
Orlando Health
RECRUITING

Orlando, Florida, 32806, United States
Penn Medicine
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Rigshospitalet
WITHDRAWN

Copenhagen, Denmark, Denmark
Royal Adelaide Hospital
RECRUITING

Adelaide, Australia, Australia
Royal Brompton Hospital
RECRUITING

London, England, United Kingdom
Ruhrlandklink, Uni Essen
RECRUITING

Essen, Germany, Germany
Saint Francis Hospital and Medical Center (Trinity Health of New England)
RECRUITING

Hartford, Connecticut, 06105, United States
Temple University
RECRUITING

Philadelphia, Pennsylvania, 19140, United States
Thoraxklinik am Universitats klinikum Heidelberg
RECRUITING

Heidelberg, Germany, Germany
UCHealth - Medical Center of the Rockies
RECRUITING

Loveland, Colorado, 80538, United States
University Medical Center Groningen
RECRUITING

Groningen, Netherlands, Netherlands
University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
University of Kentucky
RECRUITING

Lexington, Kentucky, 40536, United States
University of Pittsburgh Medical Center (UPMC)
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Texas Southwestern
RECRUITING

Dallas, Texas, 75235, United States
Universitätsklinikum Halle
RECRUITING

Halle, Germany, Germany
Wesley Hospital
RECRUITING

Brisbane, Australia, Australia

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