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A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe a new implant is and how well it works for adults with severe emphysema, a type of COPD that damages the lungs. It is for adults age 22 or older and takes place in the United States, Europe, and Brazil.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have COPD/emphysema, be age 22 or older, and sign a form agreeing to join the study.
  • Have a body mass index (BMI), a measure of weight compared with height, from 18 to 32.
  • Walk 100 to 400 meters during a 6-minute walking test.
  • Have stable disease and take less than 10 mg of prednisone, or a similar steroid dose, each day.
  • Have not smoked or vaped anything, including tobacco or marijuana, for at least 4 months before screening.
  • Have breathing test results showing FEV1 at 15% to 50% of the expected value and FEV1/FVC below 70%. These tests measure how much air you can blow out.
  • Have a CT scan showing at least 25% emphysema damage in each lung, with at least a 15% difference in damage between the upper and lower parts of at least one lung.
  • Have trapped air in the lungs above 175% of the expected amount and a breathlessness score of at least 2 on the study's scale.

Who can't join

  • Be in another study involving surgery, a procedure, or medicine; have alpha-1 antitrypsin deficiency, an inherited condition that can damage the lungs; or be a woman who could become pregnant.
  • Have more than 2 COPD flare-ups needing a hospital stay in the past year, any such flare-up within 6 weeks before the planned procedure, or at least 2 pneumonia hospital stays in the past year.
  • Have serious mucus problems, long-term swelling of the airways called chronic bronchitis, or seriously widened and damaged airways called bronchiectasis. Past lung transplant, lung tissue removal, or a procedure to reduce lung size also rules you out.
  • Have had a heart attack or unstable or uncontrolled heart failure within 6 months; have uncontrolled high blood pressure in the lungs or related right-sided heart damage; or have another heart condition that makes the implant unsafe. You must also be able to stop blood-thinning medicines safely for 7 days.
  • Have suspected lung cancer or certain CT scan findings: large air pockets taking up more than 30% of either lung, too few clear landmarks for the scan software, or less than 25% damage in every lung section.
  • Have total lung capacity below 100% of expected, oxygen transfer through the lungs below 15% or above 50% of expected, blood carbon dioxide above 50 mm Hg, or blood oxygen below 45 mm Hg while breathing room air.
  • Have a cotinine level above 13.7 ng/ml or carboxyhemoglobin above 2.5%. These tests check for nicotine exposure or carbon monoxide in the blood.
  • Have a current substance abuse disorder, major depression, schizoaffective disorder, schizophrenia, borderline personality disorder, or bipolar disorder. Other conditions that make joining unsafe or prevent finishing the study may also rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official 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-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.

Study sites (4)

CA

IL

MA

WI