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AeriSeal System for Emphysema with Collateral Ventilation

This study is evaluating the AeriSeal System in people with severe emphysema. The AeriSeal System uses a foam delivered through a bronchoscope (a thin tube inserted into the lungs) to block air leaks in the lungs, called collateral ventilation (CV). The goal is to change the CV status from positive to negative. If successful, participants will then receive a Zephyr Valve. The study aims to enroll 200 people aged 40 to 80 who have completed pulmonary rehabilitation. Success will be measured by how many participants convert from CV+ to CV- status 45 days after receiving the AeriSeal treatment. The current recruitment status is unclear.

Study design
This is an open-label, single-arm study, meaning all participants receive the AeriSeal System, and both you and the study team will know what treatment you are getting. It plans to enroll up to 200 participants.
What's involved
You would undergo a bronchoscopy procedure under general anesthesia to confirm collateral ventilation. If eligible, you would receive the AeriSeal procedure, potentially a repeat procedure, and then a Zephyr Valve if your collateral ventilation status changes.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 24 months after receiving the Zephyr Valve.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06035120

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema

Recruiting
NAAges 40–80InterventionalTreatment
Pulmonx Corporation
~200 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:AeriSeal System

At a glance

Recruiting sites
33 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Converters, responder rate
Measured over 45 days post-AeriSeal treatment (index or repeat)

Conditions

Emphysema, Pulmonary
Emphysema or COPD

Explore related trials

Chronic Obstructive Pulmonary DiseaseEmphysema

Where it's being run

36 sites across 21 states
Germany5
Pennsylvania4
France4
Illinois3
Australia3
Massachusetts2
Arizona1
Connecticut1

Study leadership

  • Narinder Shargill, PhD · STUDY_DIRECTOR · Pulmonx Corporation

Who to contact

Christina Kutzavitch, PhD
[email protected]
+1 650-216-0134
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Converters, responder rate45 days post-AeriSeal treatment (index or repeat)

    The percentage of study subjects that successfully convert from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) by Chartis.