A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema

NCT07086339 | Recruiting DMC

• 1 other identifier: IAB3-CIP
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema

Conditions

COPD; Emphysema

Keywords

IAB; Pulmair Medical; Emphysema; COPD; Lung Volume Reduction; Interventional Pulmonology; Pulmonology; COPD treatment; Emphysema treatment; lung conditions; Lung disease

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events

  The incidence of respiratory serious adverse events related to the device or procedure (SADEs) through the 90-day endpoint.

  Ninety (90) days from the last IAB implanted.

Study Arms (1)

Treatment group

EXPERIMENTAL

One or two procedures involving placement of up to 10 IAB implants in one or both lungs

Device: Implantable pulmonary stent

Interventions

Implantable pulmonary stent DEVICE

Implantable polymer based pulmonary stent for severe COPD/emphysema

Treatment group

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 of between 100 - and 400 meters
• Stable disease with less than 10-mg prednisone (or equivalent) daily
• Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
• FEV1 between 15% and 45% of predicted value at baseline exam
• FEV1/FVC \<70%
• Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -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 less than -950 HU, 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
• Women of child-bearing potential
• 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
• 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
• 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
• Suspected malignant pulmonary nodule or other lung cancer
• 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

Sponsors & Collaborators

• Pulmair Medical, Inc.: lead

Study Sites (2)

DUPUYTREN University Hospital

Limoges, 87000, France

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Lung Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

VP Clinical Operations

CONTACT

+1-858-369-0000; tkruger@pulmair.com

Clinical Study Manager

CONTACT

+1-858-369-0000; 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 17, 2025
• First Posted: July 25, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); NL (1)