Actively Recruiting
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
Led by Pulmonx Corporation · Updated on 2026-03-13
200
Participants Needed
36
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
CONDITIONS
Official Title
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and participate in the study
- Age between 40 and 80 years at consent
- Completed a documented pulmonary rehabilitation program within 12 months before baseline
- Stopped smoking for at least 8 weeks before consent, confirmed by tests
- Recent HRCT scan within 3 months showing at least one lobe with 50% emphysema destruction at -910 Hounsfield Units
- Heterogeneous emphysema defined by 15 difference in destruction score between target and non-target lobes
- Target lobes include LUL, LLL, RUL, RLL, or RUL+RML
- Interlobar fissure gap 80% complete and confined to up to 3 segments per reports
- Six-minute walk distance between 150 and 450 meters
- Clinically significant dyspnea with mMRC score 2
- Post-bronchodilation FEV1 between 15% and 45% predicted
- FEV1/FVC ratio less than 0.7
- Post-bronchodilation total lung capacity 100% predicted
- Post-bronchodilation residual volume 175% predicted
- Post-bronchodilation DLCO 20% predicted
- Received preventative respiratory vaccinations including COVID-19
- On optimal medical management >1 month before consent
- Confirmed collateral ventilation positive status by Chartis before AeriSeal procedure
You will not qualify if you...
- Prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, airway stent, pleurodesis, or bronchoscopic lung volume reduction except certain Zephyr Valve cases
- Visible lung abnormalities on HRCT like large nodules or active infections
- Post-COVID-19 lung changes such as ground glass opacities or pleural thickening
- Large bullae occupying more than one-third of the lung
- Three or more COPD hospitalizations in past 12 months or hospitalization within 8 weeks
- Primary diagnosis of asthma or chronic bronchitis with heavy sputum production
- Clinically significant bronchiectasis
- Active respiratory infection not resolved
- Requires invasive ventilatory support (CPAP or BiPAP allowed)
- Severe gas exchange abnormalities at rest (PaCO2 50 mm Hg or PaO2 <45 mm Hg)
- Pulmonary hypertension with systolic pressure >45 mm Hg
- Known alpha-1 antitrypsin deficiency
- Significant blood disorders
- Recent unexplained weight loss or other limiting comorbidities
- Non-atrial arrhythmias or EKG conduction issues
- High cardiac risk or recent cerebrovascular events
- Uncontrolled exercise-induced fainting
- Severe disease compromising treatment or survival for 12 months
- Any condition interfering with study intent or participant safety
- Intolerance to corticosteroids or antibiotics required for bronchoscopy
- Recent systemic corticosteroid or immunosuppressive use within 4 weeks
- Unable to temporarily stop certain blood thinners before procedure
- Allergy to medications or device components used in bronchoscopy
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Body mass index under 18 or over 35
- Participation in another investigational study within 30 days before consent
AI-Screening
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Trial Site Locations
Total: 36 locations
1
Banner University Medical Center
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Saint Francis Hospital and Medical Center (Trinity Health of New England)
Hartford, Connecticut, United States, 06105
Actively Recruiting
3
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61606
Actively Recruiting
7
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Brigham Lung Center
Boston, Massachusetts, United States, 02115
Withdrawn
9
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Cleveland VA Northeast
Cleveland, Ohio, United States, 44106
Withdrawn
11
Penn Medicine
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
12
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
13
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
14
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
15
Fort Sanders Regional Medical Center (StatCare)
Knoxville, Tennessee, United States, 37916
Actively Recruiting
16
University of Texas Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
17
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
18
Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
19
Royal Adelaide Hospital
Adelaide, Australia, Australia
Actively Recruiting
20
Wesley Hospital
Brisbane, Australia, Australia
Actively Recruiting
21
Macquarie University
Macquarie Park, Australia, Australia
Actively Recruiting
22
Klinik Floridsdorf
Vienna, Austria, Austria
Actively Recruiting
23
Rigshospitalet
Copenhagen, Denmark, Denmark
Withdrawn
24
CHU Limoges
Limoges, France, France
Actively Recruiting
25
Hopital Bichat-APHP
Paris, France, France
Actively Recruiting
26
CHRU Strasbourg
Strasbourg, France, France
Actively Recruiting
27
CHU Toulouse
Toulouse, France, France
Actively Recruiting
28
Ruhrlandklink, Uni Essen
Essen, Germany, Germany
Actively Recruiting
29
Universitätsklinikum Halle
Halle, Germany, Germany
Actively Recruiting
30
Asklepios Klinik Barmbek
Hamburg, Germany, Germany
Actively Recruiting
31
Thoraxklinik am Universitats klinikum Heidelberg
Heidelberg, Germany, Germany
Actively Recruiting
32
Lungenklinik Hemer
Hemer, Germany, Germany
Actively Recruiting
33
ASST Spedali Civili, University Hospital
Brescia, Italy, Italy
Actively Recruiting
34
University Medical Center Groningen
Groningen, Netherlands, Netherlands
Actively Recruiting
35
Hospital Universitario y Politecnico La Fe
Valencia, Spain, Spain
Actively Recruiting
36
Royal Brompton Hospital
London, England, United Kingdom
Actively Recruiting
Research Team
C
Christina Kutzavitch, PhD
CONTACT
M
Marie Barrigar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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