Implantable Artificial Bronchus 50 Flex for adults with severe emphysema
Official title: A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema
Run by Pulmair Medical, Inc. · NCT07086339 · Data updated 2026-11-12
This tests a small implant called the IAB 50 Flex to see if it is safe and helps adults with severe COPD or emphysema breathe and move more easily.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Pulmair Medical, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Limoges and 1 other locations) |
| Status | Recruiting |
| Started | February 4, 2026 |
| Main results expected | August 2027 |
| Study ends | December 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07086339 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe COPD or emphysema who are non-smokers for at least four months, have FEV1 between 15% and 45% predicted, RV >175% predicted, mMRC ≥2, 6-minute walk distance 100–400 m, BMI 18–32, and CT evidence of ≥25% emphysema in each lung are ideal candidates.
✕Probably not a fit
Patients with alpha-1 antitrypsin deficiency, active smoking, or whose lung function or CT pattern falls outside the study criteria are unlikely to benefit from this device in the context of this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial implants the IAB 50 Flex, an airway stent-like device, into the bronchi of adults with severe COPD/emphysema to try to reduce hyperinflation and improve symptoms. Participants are selected by lung function and CT criteria (FEV1 15–45% predicted, RV >175% predicted, mMRC ≥2, and ≥25% emphysema score on CT) and must meet other fitness and smoking-abstinence requirements. Procedures are performed at two hospital centers with follow-up to monitor safety and clinical outcomes such as exercise capacity and symptoms. The sponsor is Pulmair Medical and the study targets patients with homogeneous or heterogeneous emphysema patterns who meet the specified imaging and physiologic thresholds.
Why it matters
Potential benefit: If successful, the device could reduce lung hyperinflation and improve breathing, exercise tolerance, and daily symptom burden for selected patients.
How similar studies have gone: Other bronchoscopic lung-volume-reduction approaches such as endobronchial valves and coils have shown mixed but sometimes meaningful benefits in carefully selected patients, while implantable bronchial devices like the IAB 50 Flex are less extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
DUPUYTREN University Hospital
Limoges, France Recruiting -
University Medical Center Groningen
Groningen, Netherlands Recruiting
Study contacts
- Study coordinator: VP Clinical Operations
- Email: tkruger@pulmair.com
- Phone: +1-858-369-0000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Implant to help adults with severe emphysema
This study will test whether an implantable artificial bronchus can improve breathing and safety in adults with severe COPD/emphysema.
-
Multidisciplinary sarcopenia clinic to diagnose and treat muscle loss from COPD
This project will try a multidisciplinary sarcopenia clinic to see if it improves muscle mass, function, and overall health for COPD patients with CT-confirmed muscle loss after a hospitalization.
-
Bronchoscopic release of trapped air in hyperinflated emphysematous lungs
This trial tests if placing permanent Apreo BREATHE airway scaffold implants by bronchoscopy, together with usual medical care, helps adults with COPD and emphysema who remain short of breath from lung hyperinflation.
-
Lung cancer screening program for patients with COPD or emphysema
This study is testing if regular lung cancer screenings can help people with COPD or emphysema catch lung cancer earlier and live longer.
-
Endobronchial thermal liquid ablation for treating emphysema
This study is testing a new treatment called endobronchial thermal liquid ablation to see if it can safely help people with severe emphysema breathe better and improve their quality of life.
-
Using breath analysis to identify multiple lung diseases
This study is testing if analyzing breath samples can help identify different lung diseases like lung cancer and COPD in a large group of 10,000 people.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.