Actively Recruiting
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Led by Pulmair Medical, Inc. · Updated on 2026-05-08
60
Participants Needed
4
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
CONDITIONS
Official 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.
- Six-minute walk distance between 100 meters and 400 meters at baseline.
- Stable disease with less than 10 mg prednisone (or equivalent) daily.
- Non-smoking for 4 months prior to screening, including tobacco, vaping, and marijuana.
- Forced expiratory volume in 1 second (FEV1) between 15% and 50% of predicted value at baseline.
- FEV1/forced vital capacity (FVC) less than 70%.
- At least 25% emphysema destruction score in each lung determined by 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, 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 before planned intervention.
- Two or more pneumonia episodes requiring hospitalization in the past 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-coagulants or platelet inhibitors for 7 days.
- Uncontrolled pulmonary hypertension or history of cor pulmonale.
- Suspected malignant pulmonary nodule or lung cancer.
- Large bullae over 30% of either lung, insufficient landmarks for CT evaluation, or less than 25% diseased lung parenchyma in all lobes.
- Any cardiac condition compromising safety after IAB implant.
- Total lung capacity less than 100% predicted.
- Diffusing capacity of the lung for carbon monoxide (DLCO) less than 15% or greater than 50% predicted.
- Partial pressure of carbon dioxide (PaCO2) over 50 mm Hg.
- Partial pressure of oxygen (PaO2) less than 45 mm Hg in room air.
- Plasma cotinine level over 13.7 ng/ml or carboxyhemoglobin over 2.5%.
- Current diagnosis of substance abuse disorder.
- Current diagnosis of major depressive disorder, schizoaffective disorder, schizophrenia, borderline personality disorder, or bipolar disorder.
- Any other condition making the patient unsuitable or interfering with study participation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
V
VP Clincal 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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