Actively Recruiting
A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
Led by Pulmair Medical, Inc. · Updated on 2026-03-13
20
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent
- Diagnosis of COPD or emphysema
- At least 22 years of age
- Body mass index (BMI) between 18 and 32
- 6-minute walk distance between 100 and 400 meters
- Stable disease with less than 10 mg prednisone (or equivalent) daily
- Non-smoking for 4 months prior to screening (including tobacco, vaping, marijuana, etc.)
- FEV1 between 15% and 45% of predicted value at baseline
- FEV1/FVC less than 70%
- At least 25% emphysema destruction score in each lung defined by low attenuation areas less than -950 HU on CT scan
- Homogeneous or heterogeneous emphysema with at least 15% difference between upper and lower lobes in one lung
- Residual volume (RV) greater than 175% of predicted value
- Modified Medical Research Council (mMRC) score of 2 or higher
You will not qualify if you...
- Currently participating in another clinical study involving surgery, intervention, or pharmaceutical treatment
- Alpha-1 antitrypsin deficiency
- Women of child-bearing potential
- More than 2 COPD exacerbations requiring hospitalization in the last year
- COPD exacerbations requiring hospitalization within 6 weeks of planned intervention
- Two or more pneumonia episodes requiring hospitalization in the last year
- Clinically significant mucus production or chronic bronchitis
- Myocardial infarction or unstable/uncontrolled congestive heart failure within 6 months
- Prior lung transplant, lung volume reduction surgery, bullectomy, lobectomy, or endoscopic lung volume reduction
- Clinically significant bronchiectasis
- Unable to safely stop anti-coagulant or platelet inhibitor medications for 7 days
- Uncontrolled pulmonary hypertension or history of cor pulmonale
- Suspected malignant lung nodule or lung cancer
- Large bullae covering over 30% of either lung on recent CT
- Insufficient lung landmarks on CT for evaluation
- All lung lobes with less than 25% diseased lung tissue on CT
- Cardiac conditions compromising safety after implant
- Total lung capacity less than 100% predicted
- Diffusing capacity for carbon monoxide (DLCO) less than 15% or greater than 50% predicted
- Arterial carbon dioxide pressure (PaCO2) over 50 mm Hg
- Arterial oxygen pressure (PaO2) less than 45 mm Hg on room air
- Plasma cotinine level over 13.7 ng/ml or carboxyhemoglobin over 2.5%
- Current substance abuse disorder
- Current diagnosis of major depressive disorder, schizoaffective disorder, schizophrenia, borderline personality disorder, or bipolar disorder
- Any other condition judged by the investigator to affect safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
DUPUYTREN University Hospital
Limoges, France, 87000
Actively Recruiting
2
University Medical Center Groningen
Groningen, Netherlands
Not Yet Recruiting
Research Team
V
VP Clinical Operations
CONTACT
C
Clinical Study Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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