🏛️ Verified NIH Record • Updated 2026-03-11

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema (NCT06035120)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Pulmonx Corporation

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (32 items).

Location: Banner University Medical Center — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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.
  • 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).
  • Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms.
  • Large bullae encompassing greater than 1/3 of the total lung.
  • 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.
  • Subject has asthma as their primary diagnosis.
  • Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis.
  • Subject has clinically significant bronchiectasis.
  • Subjects with evidence of active respiratory infection should be considered for enrollment only after satisfactory resolution.
  • Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleep apnea is permitted.
  • Subject has severe gas exchange abnormalities as defined by any one of the following tests, conducted at rest, on room air, as tolerated.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (36 Sites)

  • Banner University Medical Center — Phoenix, Arizona
  • Saint Francis Hospital and Medical Center (Trinity Health of New England) — Hartford, Connecticut
  • Orlando Health — Orlando, Florida
  • Northwestern University — Chicago, Illinois
  • University of Chicago Medical Center — Chicago, Illinois
  • OSF Saint Francis Medical Center — Peoria, Illinois
  • Beth Israel Deaconess Medical Center — Boston, Massachusetts
  • Brigham Lung Center — Boston, Massachusetts
  • Henry Ford Hospital — Detroit, Michigan
  • Cleveland VA Northeast — Cleveland, Ohio
  • Penn Medicine — Philadelphia, Pennsylvania
  • Temple University — Philadelphia, Pennsylvania
  • Allegheny General Hospital — Pittsburgh, Pennsylvania
  • University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania
  • Fort Sanders Regional Medical Center (StatCare) — Knoxville, Tennessee
  • University of Texas Southwestern — Dallas, Texas
  • Inova Fairfax Hospital — Falls Church, Virginia
  • Medical College of Wisconsin (MCW) — Milwaukee, Wisconsin
  • 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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗