No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Pulmair Medical, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with severe emphysema to test a new implant. Participants will be evaluated for their suitability based on health criteria and undergo a baseline exam.
Are You a Good Fit for This Trial?
Rules you outα-1 Antitrypsin deficiencySevere lung cancerSubstance abuse disorder
You may be able to join if
I have been diagnosed with COPD or emphysema
I am at least 22 years old
My BMI is between 18 and 32
I can walk between 100 and 400 meters in 6 minutes
I have stable disease and take less than 10 mg of prednisone daily
I have not smoked for 4 months
My FEV1 is between 15% and 50% of the predicted value
I have at least 25% emphysema destruction in each lung
You may not be able to join if
I am currently in another clinical study involving surgery or treatment
I have a history of severe pneumonia requiring hospitalization in the past year
I have had a heart attack or unstable heart failure in the past 6 months
I cannot stop blood thinners for a week before the procedure
I have uncontrolled high blood pressure in the lungs
I have a current diagnosis of a major mental health disorder
I have a significant lung condition like bronchiectasis
I have any other health issues that would make me unsuitable for the trial
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
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-m…
Inclusion Criteria:
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.
9. FEV1/FVC \<70%.
10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \<-950 HU, as determined by CT core lab.
11. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (\< -950HU) as determined by CT core lab.
12. RV \> 175% of predicted value.
13. mMRC score ≥ 2.
Exclusion Criteria:
* 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.
13\. Suspected malignant pulmonary nodule or other lung cancer. 14. HRCT collected per CT scanning protocol within the last 6-months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
1. Large bullae encompassing greater than 30% of either lung
2. Insufficient landmarks to evaluate the CT study using the software as it is intended
3. All lobes are less than 25% parenchyma diseased (\< -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
16\. TLC \< 100% predicted at screening. 17. DLCO \< 15% or \> 50% of predicted value at screening. 18. PaCO2 \> 50 mm Hg at screening. 19. PaO2 \< 45 mm Hg in room air at screening. 20. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \>2.5% at screening.
21\. Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.
23\. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.