RecruitingNot ApplicableNCT06035120

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

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

Sponsor

Pulmonx Corporation

Enrollment

200 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Emphysema or COPD Emphysema, Pulmonary

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.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the AeriSeal System — a substance injected into damaged lung segments through a scope — can seal off abnormal air passages in patients with severe emphysema who are being considered for a lung valve procedure. **You may be eligible if...** - You are between 40 and 80 years old - You have severe emphysema confirmed on a high-resolution CT scan - You have stopped smoking for at least 8 weeks - You have completed a pulmonary rehabilitation program in the past year - Your breathing tests show significant lung obstruction and air trapping - You experience significant breathlessness with daily activities **You may NOT be eligible if...** - Your emphysema is evenly distributed throughout the lungs (homogeneous) - Your breathing function is extremely poor (FEV1 below 15% predicted) - You have had a recent serious lung infection or are on a lung transplant list - You have significant other conditions making the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAeriSeal 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.

Locations(36)

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, Australia

Wesley Hospital

Brisbane, Australia, Australia

Macquarie University

Macquarie Park, Australia, Australia

Klinik Floridsdorf

Vienna, Austria, Austria

Rigshospitalet

Copenhagen, Denmark, Denmark

CHU Limoges

Limoges, France, France

Hopital Bichat-APHP

Paris, France, France

CHRU Strasbourg

Strasbourg, France, France

CHU Toulouse

Toulouse, France, France

Ruhrlandklink, Uni Essen

Essen, Germany, Germany

Universitätsklinikum Halle

Halle, Germany, Germany

Asklepios Klinik Barmbek

Hamburg, Germany, Germany

Thoraxklinik am Universitats klinikum Heidelberg

Heidelberg, Germany, Germany

Lungenklinik Hemer

Hemer, Germany, Germany

ASST Spedali Civili, University Hospital

Brescia, Italy, Italy

University Medical Center Groningen

Groningen, Netherlands, Netherlands

Hospital Universitario y Politecnico La Fe

Valencia, Spain, Spain

Royal Brompton Hospital

London, England, United Kingdom

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