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A Multi Center Study Testing a New Implant for Adults With Severe Emphysema | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema

NCT07119229•Pulmair Medical, Inc.

View on ClinicalTrials.gov

Summary

A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.

Detailed Description

IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed Informed Consent.
•2. Diagnosis of COPD/emphysema.
•3. At least 22-years of age.
•4. 18 ≤ BMI ≤ 32.
•5. 6-minute walk Distance between 100-meters and 400-meters at baseline exam.
•6. Stable disease with less than 10-mg prednisone (or equivalent) daily
•7. Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
•8. FEV1 between 15% and 50% of predicted value at baseline exam.
•9. FEV1/FVC \<70%.
•10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \<-950 HU, as determined by CT core lab.
+3 more criteria

Exclusion Criteria

•1\. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
•2\. α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.
•5\. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
•6\. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
•7\. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
•9\. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).
•10\. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.
•12\. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3-months prior to screening visit). Note: the echocardiogram is not a required screening procedure.
•13\. Suspected malignant pulmonary nodule or other lung cancer. 14. HRCT collected per CT scanning protocol within the last 6-months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
•1. Large bullae encompassing greater than 30% of either lung
+5 more criteria

Locations (2)

Northwestern University

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

July 1, 2027

Completion Date

November 1, 2027

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Emphysema or COPDEmphysemaCOPD

Interventions

Implantable Artificial Bronchus

DEVICE

Contacts

VP Clincal Operations

CONTACT

858-369-0000 tkruger@pulmair.com

Clinical Study Manager

CONTACT

858-369-0000 mgil@pulmair.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

Inclusion Criteria

Exclusion Criteria

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