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

NCT07119229 | Recruiting DMC FDA Device

• 1 other identifier: IAB2-CIP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Emphysema or COPD; Emphysema; COPD

Keywords

IAB; Stent; Emphysema treatment; emphysema study; COPD treatment; COPD study; EBV alternative; Lung volume reduction; Lung hyperinflation treatment

Outcome Measures

Primary Outcomes (1)

• Absolute change in residual volume (RV)

  The primary endpoint is the absolute change in residual volume (RV) from baseline to endpoint as recorded 90-days after the last implant.

  90 days after last IAB is implanted

Secondary Outcomes (1)

• Changes from baseline to 90-days, involving pulmonary function, exercise tolerance, dyspnea burden and occurrence as well as all related adverse device effects

  90 days after last implant

Study Arms (1)

All subjects will receive study treatment

EXPERIMENTAL

All subjects will receive treatment with a maximum of 10 Implantable Artificial Bronchus (IABs) which are polymer based stents that can be permanently placed in any diseased lobe of the lungs.

Device: Implantable Artificial Bronchus

Interventions

Implantable Artificial Bronchus DEVICE

The Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema.

Also known as: IAB

All subjects will receive study treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent.
• Diagnosis of COPD/emphysema.
• At least 22-years of age.
• ≤ BMI ≤ 32.
• minute walk Distance between 100-meters and 400-meters at baseline exam.
• Stable disease with less than 10-mg prednisone (or equivalent) daily
• Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
• FEV1 between 15% and 50% of predicted value at baseline exam.
• FEV1/FVC \<70%.
• Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \<-950 HU, as determined by CT core lab.
• Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (\< -950HU) as determined by CT core lab.
• RV \> 175% of predicted value.
• mMRC score ≥ 2.

You may not qualify if:

• \. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
• \. 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.
• \. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
• \. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
• \. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
• \. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).
• \. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.
• \. 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.
• \. 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:
• Large bullae encompassing greater than 30% of either lung
• Insufficient landmarks to evaluate the CT study using the software as it is intended
• All lobes are less than 25% parenchyma diseased (\< -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
• \. TLC \< 100% predicted at screening. 17. DLCO \< 15% or \> 50% of predicted value at screening. 18. PaCO2 \> 50 mm Hg at screening. 19. PaO2 \< 45 mm Hg in room air at screening. 20. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \>2.5% at screening.
• \. Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.

Sponsors & Collaborators

• Pulmair Medical, Inc.: lead

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Adnan Majid, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VP Clincal Operations

CONTACT

858-369-0000; tkruger@pulmair.com

Clinical Study Manager

CONTACT

858-369-0000; mgil@pulmair.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 13, 2025
• Study Start: March 25, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)