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A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema
Led by Pulmair Medical, Inc. · Updated on 2026-06-03
60
Participants Needed
3
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new therapy called the Implantable Artificial Bronchus (IAB) for adults with severe COPD or emphysema. This open-label, multicenter trial involves up to twelve sites in the United States and three sites in the Netherlands, Germany, and Brazil. The study aims to assess how well the IAB works and its safety in adults suffering from this lung condition. There is no control group in this study, focusing solely on those receiving the treatment. Participants will receive up to 10 polymer-based airway stents called Implantable Artificial Bronchi, which are placed permanently into diseased lung lobes through a bronchoscopic procedure using a special delivery system. The treatment is given in one study group where all subjects receive the IAB device. The therapy is designed to support lung function by targeting damaged areas in the lungs affected by emphysema. During the study, participants will be monitored through various assessments including pulmonary function tests, exercise tolerance, and questionnaires measuring breathlessness. Researchers will track changes in lung volume and other lung function measures 90 days after the last implant. Safety will be evaluated by recording any adverse effects related to the device. The total study duration and detailed follow-up procedures are designed to thoroughly understand the treatment's impact on lung health.
CONDITIONS
Brief Title
A Multi Center Study Testing a New Implant for Adults 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.
- Able to walk between 100 and 400 meters in 6 minutes at baseline.
- Stable disease with less than 10 mg prednisone (or equivalent) daily.
- Non-smoking for at least 4 months prior to screening (including tobacco, vaping, marijuana).
- FEV1 between 15% and 50% of predicted value at baseline.
- FEV1/FVC ratio less than 70%.
- Emphysema destruction score of 25% or more in each lung by CT scan.
- At least one lung has a 15% difference in emphysema destruction between upper and lower lobes.
- Residual volume (RV) greater than 175% of predicted value.
- Modified Medical Research Council (mMRC) breathlessness score 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 past year.
- COPD exacerbation requiring hospitalization within 6 weeks before planned intervention.
- Two or more pneumonia hospitalizations in the past year.
- Clinically significant mucus production or chronic bronchitis.
- Recent myocardial infarction or unstable heart failure within 6 months.
- Prior lung surgeries such as transplant, lung volume reduction, bullectomy, or lobectomy.
- Clinically significant bronchiectasis.
- Unable to safely stop anticoagulants or platelet inhibitors for 7 days.
- Uncontrolled pulmonary hypertension or cor pulmonale.
- Suspicion of lung cancer.
- Large bullae covering more than 30% of lung or insufficient landmarks on CT.
- Cardiac conditions that may compromise safety after implant.
- Total lung capacity (TLC) less than 100% predicted.
- Diffusing capacity of the lungs for carbon monoxide (DLCO) less than 15% or more than 50% predicted.
- High levels of carbon dioxide or low oxygen in blood at screening.
- Elevated plasma cotinine or carboxyhemoglobin levels.
- Current substance abuse disorder.
- Diagnosis of major psychiatric disorders including major depressive disorder, schizophrenia, bipolar disorder, or borderline personality disorder.
- Any other conditions that the investigator believes would interfere with participation or safety.
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 - Not specified
Participants receive implantation of up to 10 Implantable Artificial Bronchus (IAB) devices bronchoscopically into diseased lung lobes.
1 implantation visit (in-person)
Duration - 90 days after last implant
Participants are monitored for safety and efficacy outcomes including lung function, exercise tolerance, breathlessness, and adverse device effects.
Follow-up visits during 90 days post-implant
Trial Site Locations
Total: 3 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
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2
Northwestern University
Chicago, Illinois, United States, 60611
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3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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Research Team
V
VP Clincal 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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