Actively Recruiting
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial
Led by Pulmonx Corporation · Updated on 2026-03-13
200
Participants Needed
36
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the AeriSeal System in patients with severe, heterogeneous emphysema who have collateral ventilation (CV) in the lung lobe targeted for treatment. The study is prospective, open-label, and conducted at multiple centers, including up to 200 subjects. Participants must be candidates for bronchoscopic lung volume reduction (BLVR) and will be followed for 24 months to assess safety and effectiveness. Participants meeting eligibility will undergo a bronchoscopy under general anesthesia to confirm CV status using the Chartis system. All enrolled subjects will receive the AeriSeal procedure to block collateral ventilation by closing lung fissure gaps. If CV status remains positive after the first treatment, a repeat AeriSeal treatment may be performed, with volume limits. Subjects who convert from CV positive to CV negative will then receive BLVR with a Zephyr Valve. Follow-up continues through 24 months for all participants. During the study, researchers will assess the conversion of collateral ventilation status 45 days after AeriSeal treatment as the primary outcome. Additional measures include lung function tests such as forced expiratory volume (FEV1), residual volume (RV), treated lobe volume reduction by CT scan, and quality of life questionnaires at 6 months after Zephyr Valve placement. Safety assessments and monitoring will continue throughout the study period, lasting up to two years per participant.
CONDITIONS
Brief 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...
- Subject is willing and able to provide informed consent and participate.
- Age 40 to 80 years at the time of consent.
- Completed pulmonary rehabilitation within 12 months prior to baseline.
- Stopped smoking for at least 8 weeks prior to consent.
- Recent HRCT scan within 3 months showing at least one lobe with segmental emphysema destruction score 60 50% and heterogeneous emphysema.
- Target lobes include LUL, LLL, RUL, RLL, or RUL+RML.
- Fissure completeness 60 80% and fissure gap confined to 4 segments.
- Six-minute walk distance between 150 m and 450 m.
- Clinically significant dyspnea with mMRC score 60 2.
- Post-bronchodilation FEV1 between 15% and 45% predicted.
- FEV1/FVC ratio C 0.7.
- Post-bronchodilation TLC 60 100% predicted.
- Post-bronchodilation RV 60 175% predicted.
- Post-bronchodilation DLCO 60 20% predicted.
- Received preventative respiratory vaccinations including COVID-19.
- On optimal medical management for more than one month prior to consent.
- Confirmed collateral ventilation positive status by Chartis assessment prior to AeriSeal procedure.
You will not qualify if you...
- Prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplantation, airway stent, pleurodesis, or BLVR except certain Zephyr Valve cases.
- Pulmonary nodules > 0.8 cm or active pulmonary infection on HRCT.
- Post-COVID-19 lung pathology on CT.
- Large bullae covering more than one-third of total lung.
- Three or more COPD hospitalizations in past year or recent hospitalization within 8 weeks.
- Primary diagnosis of asthma or chronic bronchitis.
- Clinically significant bronchiectasis or active respiratory infection.
- Requires invasive ventilatory support; CPAP or BiPAP allowed.
- Severe gas exchange abnormalities (high PaCO2 or low PaO2).
- Pulmonary hypertension with systolic pressure > 45 mm Hg.
- Known alpha-1 antitrypsin deficiency.
- Significant hematological disorders or recent unexplained weight loss.
- Non-atrial arrhythmias or conduction abnormalities.
- High cardiac risk or ischemic heart disease, heart failure, recent stroke, poor kidney function, low ejection fraction.
- Uncontrolled exercise-induced syncope.
- Severe disease compromising treatment effect or survival.
- Conditions interfering with study intent or compliance.
- Corticosteroid or antibiotic intolerance.
- Recent use of high dose systemic corticosteroids or immunosuppressive agents.
- Unable to stop certain blood thinners as required.
- Allergies to bronchoscopy medications or device materials.
- Pregnancy, breastfeeding, or planning pregnancy.
- Body mass index less than 18 or greater than 35.
- Recent participation in other investigational studies not approved for marketing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day 0 (procedure day)
Participants undergo the AeriSeal procedure, which involves a bronchoscopy to deliver AeriSeal Foam to targeted lung regions to block collateral ventilation.
1 procedure visit (in-person)
Duration - Within 45 days post-initial procedure
Participants not converted from collateral ventilation positive to negative status after the initial AeriSeal procedure may undergo a repeat AeriSeal procedure, with volume limits applied.
1 repeat procedure visit if applicable (in-person)
Duration - Post-conversion until Month 24
Participants who convert to collateral ventilation negative status after either the initial or repeat AeriSeal procedure undergo bronchoscopic lung volume reduction (BLVR) with the Zephyr Valve per standard of care.
Follow-up visits during 24 months after BLVR (visit frequency per standard of care)
Duration - Up to 24 months
Participants who remain collateral ventilation positive after repeat AeriSeal procedure or who do not undergo repeat procedure are followed for safety and outcomes through Month 24.
Follow-up visits during 24 months (visit frequency per standard of care)
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
M
Marie Barrigar
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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