NCT06035120

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
9 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Feb 2024Mar 2028

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

September 5, 2023

Last Update Submit

March 11, 2026

Conditions

Emphysema or COPDEmphysema, Pulmonary

Keywords

Collateral VentilationBronchoscopic Lung Volume ReductionHyperinflation

Outcome Measures

Primary Outcomes (1)

  • Converters, responder rate

    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 Outcomes (4)

  • Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate

    Month 6 post-Zephyr Valve

  • Residual volume (RV), responder rate

    Month 6 post-Zephyr Valve

  • Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), responder rate

    Month 6 post-Zephyr Valve

  • St. George's Respiratory Questionnaire (SGRQ), responder rate

    Month 6 post-Zephyr Valve

Other Outcomes (16)

  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) change

    Month 3, Month 6, Month 12, Month 24

  • Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate

    Month 3, Month 12, Month 24

  • Residual volume (RV), responder rate

    Month 3, Month 12, Month 24

  • +13 more other outcomes

Study Arms (1)

AeriSeal

EXPERIMENTAL

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

Interventions

AeriSeal SystemDEVICE

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.

AeriSeal

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing and able to provide informed consent and to participate in the study.
  • Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
  • Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.
  • Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
  • 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:
  • At least one (1) lobe with segmental emphysema destruction score ≥ 50%.
  • 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.
  • LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
  • 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.
  • Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR).
  • Subject has 6MWD ≥ 150 m and ≤ 450 m.
  • Subject has clinically significant dyspnea with an mMRC score of ≥ 2.
  • Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted.
  • Subject has an FEV1/FVC ratio of \< 0.7.
  • Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted.
  • +5 more criteria

You may not qualify if:

  • 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.
  • PaCO2 ≥ 50 mm Hg (6.7 kPa)
  • PaO2 \< 45 mm Hg (6.0 kPa)
  • Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure \> 45 mm Hg.
  • Subject has known documented alpha-1 antitrypsin deficiency.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

RECRUITING

Saint Francis Hospital and Medical Center (Trinity Health of New England)

Hartford, Connecticut, 06105, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61606, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham Lung Center

Boston, Massachusetts, 02115, United States

WITHDRAWN

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Cleveland VA Northeast

Cleveland, Ohio, 44106, United States

WITHDRAWN

Penn Medicine

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Fort Sanders Regional Medical Center (StatCare)

Knoxville, Tennessee, 37916, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75235, United States

RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Medical College of Wisconsin (MCW)

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Royal Adelaide Hospital

Adelaide, Australia, Australia

RECRUITING

Wesley Hospital

Brisbane, Australia, Australia

RECRUITING

Macquarie University

Macquarie Park, Australia, Australia

RECRUITING

Klinik Floridsdorf

Vienna, Austria, Austria

RECRUITING

Rigshospitalet

Copenhagen, Denmark, Denmark

WITHDRAWN

CHU Limoges

Limoges, France, France

RECRUITING

Hopital Bichat-APHP

Paris, France, France

RECRUITING

CHRU Strasbourg

Strasbourg, France, France

RECRUITING

CHU Toulouse

Toulouse, France, France

RECRUITING

Ruhrlandklink, Uni Essen

Essen, Germany, Germany

RECRUITING

Universitätsklinikum Halle

Halle, Germany, Germany

RECRUITING

Asklepios Klinik Barmbek

Hamburg, Germany, Germany

RECRUITING

Thoraxklinik am Universitats klinikum Heidelberg

Heidelberg, Germany, Germany

RECRUITING

Lungenklinik Hemer

Hemer, Germany, Germany

RECRUITING

ASST Spedali Civili, University Hospital

Brescia, Italy, Italy

RECRUITING

University Medical Center Groningen

Groningen, Netherlands, Netherlands

RECRUITING

Hospital Universitario y Politecnico La Fe

Valencia, Spain, Spain

RECRUITING

Royal Brompton Hospital

London, England, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary EmphysemaEmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Narinder Shargill, PhD

    Pulmonx Corporation

    STUDY DIRECTOR

Central Study Contacts

Christina Kutzavitch, PhD

CONTACT

+1 650-216-0134ckutzavitch@pulmonx.com

Marie Barrigar

CONTACT

marie.barrigar@pulmonx.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study is designed as a single-arm clinical trial in which eligible subjects with an identified fissure gap in the target lobe will be treated with the AeriSeal System to determine the rate of conversion from having collateral ventilation (CV+) to having little to no collateral ventilation (CV-). Subjects who convert to CV- status with AeriSeal will then undergo BLVR using Zephyr Valve per standard of care.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

February 22, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

AU(1)US(18)ES(1)FR(4)DK(1)GB(1)IT(1)DE(5)NL(1)