An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
NCT ID: NCT06035120
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-02-22
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AeriSeal
All enrolled subjects meeting final eligibility will undergo the AeriSeal procedure to block collateral ventilation by closing the lobar fissure gaps or collateral air channels.
AeriSeal System
The AeriSeal System comprises AeriSeal Foam and the AeriSeal Balloon Catheter Preparation Kit that is used for bronchoscopic delivery of AeriSeal Foam to the targeted regions of the lung.
Interventions
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AeriSeal System
The AeriSeal System comprises AeriSeal Foam and the AeriSeal Balloon Catheter Preparation Kit that is used for bronchoscopic delivery of AeriSeal Foam to the targeted regions of the lung.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
ALL
No
Sponsors
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Pulmonx Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Narinder Shargill, PhD
Role: STUDY_DIRECTOR
Pulmonx Corporation
Locations
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Banner University Medical Center
Phoenix, Arizona, United States
Saint Francis Hospital and Medical Center (Trinity Health of New England)
Hartford, Connecticut, United States
Orlando Health
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham Lung Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cleveland VA Northeast
Cleveland, Ohio, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Fort Sanders Regional Medical Center (StatCare)
Knoxville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, , Australia
Wesley Hospital
Brisbane, , Australia
Macquarie University
Macquarie Park, , Australia
Klinik Floridsdorf
Vienna, , Austria
Rigshospitalet
Copenhagen, , Denmark
CHU Limoges
Limoges, , France
Hopital Bichat-APHP
Paris, , France
CHRU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
Ruhrlandklink, Uni Essen
Essen, , Germany
Universitätsklinikum Halle
Halle, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Thoraxklinik am Universitats klinikum Heidelberg
Heidelberg, , Germany
Lungenklinik Hemer
Hemer, , Germany
ASST Spedali Civili, University Hospital
Brescia, , Italy
University Medical Center Groningen
Groningen, , Netherlands
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Royal Brompton Hospital
London, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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630-2000-01
Identifier Type: -
Identifier Source: org_study_id
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