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A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema
Led by Pulmair Medical, Inc. · Updated on 2026-06-03
20
Participants Needed
2
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex), a new implant for adults who have severe COPD or emphysema. This trial is conducted at two hospitals and aims to study the implant's impact on patients with these serious lung conditions. The study is sponsored by Pulmair Medical, Inc. and does not involve masking or blinding. Participants will undergo one or two procedures to place up to 10 polymer-based IAB implants in one or both lungs. These implants are designed to support the lungs affected by COPD or emphysema. The trial involves only the treatment group receiving the implant, with no comparison to placebo or other treatments. During the study, participants will be monitored for safety, focusing on the incidence of serious adverse events within 90 days after the last implant procedure. Researchers will assess lung function and disease stability through various tests and clinical evaluations. The study starts in February 2026 and will continue through December 2027, with participants undergoing screening and follow-up visits to evaluate treatment effects and overall health.
CONDITIONS
Brief 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 at least 4 months prior to screening
- FEV1 between 15% and 45% of predicted value at baseline
- FEV1/FVC less than 70%
- Emphysema destruction score of at least 25% in each lung by CT scan
- Homogeneous or heterogeneous emphysema with at least 15% difference between lobes
- Residual volume (RV) greater than 175% of predicted value
- mMRC score of 2 or higher
You will not qualify if you...
- Currently participating in another clinical study involving surgery, interventional or pharmaceutical treatment
- Alpha-1 antitrypsin deficiency
- Women of child-bearing potential
- More than 2 COPD exacerbations requiring hospitalization in the past year
- COPD exacerbations requiring hospitalization within 6 weeks prior to intervention
- Two or more pneumonia episodes requiring hospitalization in the past year
- Clinically significant mucus production or chronic bronchitis
- Recent 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-coagulants or platelet inhibitors for 7 days
- Uncontrolled pulmonary hypertension or history of cor pulmonale
- Suspected lung cancer or malignant pulmonary nodule
- Large bullae encompassing more than 30% of either lung on recent CT scan
- Insufficient landmarks for CT evaluation
- All lobes with less than 25% diseased lung tissue
- Any cardiac condition deemed unsafe for IAB implant by investigator
- Total lung capacity less than 100% predicted
- DLCO less than 15% or greater than 50% predicted
- PaCO2 greater than 50 mm Hg at screening
- PaO2 less than 45 mm Hg in room air at screening
- Plasma cotinine level greater than 13.7 ng/ml or carboxyhemoglobin over 2.5%
- Current diagnosis of substance abuse disorder
- Diagnosis of major depressive disorder, schizoaffective disorder, schizophrenia, borderline personality disorder, or bipolar disorder
- Any other condition that would make participation unsuitable or interfere with study completion as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day or up to 2 procedures
Participants undergo one or two procedures involving placement of up to 10 implantable artificial bronchus (IAB) stents in one or both lungs.
1 to 2 visits depending on the number of implant procedures
Duration - 90 days from the last implant
Participants are monitored for safety including incidence of serious adverse events for 90 days following the last implant procedure.
Multiple follow-up visits over 90 days
Trial Site Locations
Total: 2 locations
1
DUPUYTREN University Hospital
Limoges, France, 87000
Actively Recruiting
2
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
V
VP Clinical Operations
C
Clinical Study Manager
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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