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

March 11, 2026 updated by: Pulmonx Corporation

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective, single-arm, pivotal trial with a 24-month follow-up to evaluate the safety and effectiveness of the AeriSeal System to block CV. The study plans to enroll up to 200 subjects at up to 35 clinical centers in US and OUS. Study subjects will be patients with severe, heterogeneous emphysema and collateral ventilation in the lobe targeted who are candidates for BLVR. Subjects meeting initial eligibility will undergo a bronchoscopy procedure under general anesthesia during which the presence of CV will be confirmed using Chartis. All enrolled subjects meeting final eligibility will undergo the AeriSeal procedure. Conversion of collateral ventilation status from CV+ to CV- in the target lobe will be evaluated by Chartis at Day 45 post-AeriSeal treatment (primary effectiveness endpoint). All subjects not converted from CV+ to CV- status will undergo a repeat of the AeriSeal procedure, provided that the total volume from both the initial and the repeat treatments does not exceed 40 mL in up to 3 segments. All subjects converted from CV+ to CV- status after either the index or repeat AeriSeal procedure will undergo BLVR with Zephyr Valve per standard of care in accordance with the approved instructions for use and will be followed through Month 24 (end of study). All CV+ subjects who remain CV+ after the repeat procedure or do not undergo the repeat AeriSeal procedure will be followed through Month 24 (end of study).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
  • Austria
  • Denmark
    • Denmark
      • Copenhagen, Denmark, Denmark
        • Withdrawn
        • Rigshospitalet
  • France
  • Germany
  • Italy
  • Netherlands
    • Netherlands
      • Groningen, Netherlands, Netherlands
        • Recruiting
        • University Medical Center Groningen
        • Principal Investigator:
          • Dirk-Jan Slebos, MD
        • Contact:
        • Contact:
  • Spain
    • Spain
      • Valencia, Spain, Spain
        • Recruiting
        • Hospital Universitario y Politécnico La FE
        • Contact:
        • Principal Investigator:
          • Enrique Cases Viedma, MD
        • Contact:
  • United Kingdom
    • England
      • London, England, United Kingdom
        • Recruiting
        • Royal Brompton Hospital
        • Principal Investigator:
          • Pallav Shah, MD
        • Contact:
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • Connecticut
      • Hartford, Connecticut, United States, 06105
    • Florida
    • Illinois
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02115
        • Withdrawn
        • Brigham Lung Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Avi Cohen, MD
        • Contact:
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Withdrawn
        • Cleveland VA Northeast
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Baltaji, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center (UPMC)
        • Principal Investigator:
          • Frank Sciurba, MD
        • Contact:
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • Fort Sanders Regional Medical Center (StatCare)
        • Contact:
        • Principal Investigator:
          • Varun Shah, MD
        • Contact:
    • Texas
    • Virginia
      • Falls Church, Virginia, United States, 22042
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin (MCW)
        • Principal Investigator:
          • Jonathan Kurman, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is willing and able to provide informed consent and to participate in the study.
  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:

  1. 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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Converters, responder rate
Time Frame: 45 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.
45 days post-AeriSeal treatment (index or repeat)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate
Time Frame: Month 6 post-Zephyr Valve
The percentage of converters achieving a ≥ 12% increase in FEV1
Month 6 post-Zephyr Valve
Residual volume (RV), responder rate
Time Frame: Month 6 post-Zephyr Valve
The percentage of converters achieving a ≥ 310 mL decrease in RV
Month 6 post-Zephyr Valve
Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), responder rate
Time Frame: Month 6 post-Zephyr Valve
The percentage of converters achieving a ≥ 350 mL decrease in TLVR
Month 6 post-Zephyr Valve
St. George's Respiratory Questionnaire (SGRQ), responder rate
Time Frame: Month 6 post-Zephyr Valve
The percentage of converters achieving a ≥ 4-point decrease in SGRQ total score
Month 6 post-Zephyr Valve

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-bronchodilator forced expiratory volume in 1 second (FEV1) change
Time Frame: Month 3, Month 6, Month 12, Month 24
Absolute, percent and percent predicted change
Month 3, Month 6, Month 12, Month 24
Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate
Time Frame: Month 3, Month 12, Month 24
Percentage of subjects achieving a ≥12% increase
Month 3, Month 12, Month 24
Residual volume (RV), responder rate
Time Frame: Month 3, Month 12, Month 24
The percentage of subjects achieving a ≥ 310 mL decrease in RV
Month 3, Month 12, Month 24
Residual volume (RV), change
Time Frame: Day 45, Month 6, Month 12
Absolute and percent predicted change in RV
Day 45, Month 6, Month 12
Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), change
Time Frame: Day 45, Month 6, Month 12
Absolute change in TLVR
Day 45, Month 6, Month 12
Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), responder rate
Time Frame: Day 45, Month 12
The percentage of subjects achieving a ≥ 350 mL decrease in TLVR
Day 45, Month 12
Residual volume to total lung capacity (RV/TLC) ratio
Time Frame: Month 3, Month 6, Month 12, Month 24
Absolute change in RV/TLC ratio
Month 3, Month 6, Month 12, Month 24
Forced vital capacity (FVC), change
Time Frame: Month 3, Month 6, Month 12, Month 24
Absolute and percent change in FVC
Month 3, Month 6, Month 12, Month 24
Diffusion capacity of carbon monoxide (DLCO), change
Time Frame: Month 6, Month 12
Absolute and percent predicted change in DLCO
Month 6, Month 12
Chronic Obstructive Pulmonary Disease assessment test (CAT), change
Time Frame: Month 3, Month 6, Month 12
Absolute change. Minimum score: 0, maximum score: 40. Lower scores indicate a better outcome.
Month 3, Month 6, Month 12
Chronic Obstructive Pulmonary Disease assessment test (CAT), responder rate
Time Frame: Month 3, Month 6, Month 12
The percentage of subjects achieving a ≥ 2-point decrease
Month 3, Month 6, Month 12
St. George's Respiratory Questionnaire (SGRQ), total score change
Time Frame: Month 3, Month 6, Month 12
Absolute change in SGRQ total score. Minimum score: 0, maximum score: 100. Lower scores indicate a better outcome.
Month 3, Month 6, Month 12
St. George's Respiratory Questionnaire (SGRQ), responder rate
Time Frame: Month 3, Month 12
The percentage of converters achieving a ≥ 4-point decrease in SGRQ total score
Month 3, Month 12
Six Minute Walking Test (6MWT), responder rate
Time Frame: Month 6, Month 12
Percentage of subjects achieving a ≥ 26 meter increase
Month 6, Month 12
Modified Medical Research Council (mMRC) Dyspnea Scale, total score change
Time Frame: Month 3, Month 6, Month 12
Absolute change in total mMRC Dyspnea Scale score. Minimum score: 0, maximum score: 4. Lower scores indicate a better outcome.
Month 3, Month 6, Month 12
Modified Medical Research Council (mMRC) Dyspnea Scale, responder rate
Time Frame: Month 3, Month 6, Month 12
The percentage of subjects achieving a ≥ 1-point decrease
Month 3, Month 6, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmonx Corporation

Investigators

  • Study Director: Narinder Shargill, PhD, Pulmonx Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 630-2000-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be aggregated and analyzed. No IPD be made available for sharing to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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