A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema (IAB-3)

A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema

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

Study Overview

• Status: Recruiting
• Conditions: Emphysema; COPD
• Intervention / Treatment: Device: Implantable pulmonary stent

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VP Clinical Operations; Phone Number: +1-858-369-0000; Email: tkruger@pulmair.com
• Study Contact Backup: Name: Clinical Study Manager; Phone Number: +1-858-369-0000; Email: mgil@pulmair.com

Study Locations

• France
  • Limoges, France, 87000
    • Recruiting
    • DUPUYTREN University Hospital
    • Contact: Clinical Research Associate; Phone Number: 05 55 08 73 70; Email: elisa.dore@chu-limoges.fr
    • Principal Investigator: Thomas Egenod, Medical Doctor
• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • University Medical Center Groningen
    • Contact: Study Coordinator; Phone Number: 050-3619194; Email: j.hartman@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 of between 100 - and 400 meters
6. Stable disease with less than 10-mg prednisone (or equivalent) daily
7. Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
8. FEV1 between 15% and 45% 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 less than -950 HU, as determined by CT core lab.
11. 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.
12. RV > 175% of predicted value.
13. mMRC score ≥ 2

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
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:

    • 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
16. 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.
21. 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
23. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; One or two procedures involving placement of up to 10 IAB implants in one or both lungs	Device: Implantable pulmonary stent; Implantable polymer based pulmonary stent for severe COPD/emphysema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Pulmair Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 17, 2025
• First Submitted That Met QC Criteria: July 17, 2025
• First Posted (Actual): July 25, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Emphysema; COPD treatment; Lung disease; Lung Volume Reduction; Pulmonology; Interventional Pulmonology; IAB; Pulmair Medical; Emphysema treatment; lung conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Emphysema
• Other Study ID Numbers: IAB3-CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No