RecruitingEmphysema or COPDEmphysemaCOPD
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Eligible age
22+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Pulmair Medical, Inc.
You may qualify if…
- ✓ 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 between 100-meters and 400-meters at baseline exam.
- ✓ 6. Stable disease with less than 10-mg prednisone (or equivalent) daily
- ✓ 7. Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
- ✓ 8. FEV1 between 15% and 50% of predicted value at baseline exam.
You may not qualify if…
- ✕ 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 (completed within the last 3-months prior to screening visit). Note: the echocardiogram is not a required screening procedure.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07119229 · last updated 2026-06-03