Tests an implanted airway stent in adults with severe emphysema

Trial details

Who runs it

Pulmair Medical, Inc.

Trial code

NCT07086339

Record updated

3 June 2026

Original description

A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or EmphysemaRead full original descriptionShow less

A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema

A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema

Inclusion: Signed Informed Consent; Diagnosis of COPD/emphysema; At least 22-years of age; 18 ≤ BMI ≤ 32; 6-minute walk Distance of between 100 - and 400 meters; Stable disease with less than 10-mg prednisone (or equivalent) daily; Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.); FEV1 between 15% and 45% of predicted value at baseline exam; FEV1/FVC <70%; Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab; Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab; RV > 175% of predicted value; mMRC score ≥ 2.

Exclusion: Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment; More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening; Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening; Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR); Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening; Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram; Suspected malignant pulmonary nodule or other lung cancer; Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant; Current diagnosis of substance abuse disorder; Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder; 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; Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days; α-1 Antitrypsin deficiency; Women of child-bearing potential; Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention; Clinically significant mucus production or chronic bronchitis; Clinically significant bronchiectasis; 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:; Large bullae encompassing greater than 30% of either lung; Insufficient landmarks to evaluate the CT study using the software as it is intended; All lobes are less than 25% parenchyma diseased (< -950 HU); TLC < 100% predicted at screening; DLCO < 15% or > 50% of predicted value at screening; PaCO2 > 50 mm Hg at screening; PaO2 < 45 mm Hg in room air at screening; Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.

ClinicalTrials.gov NCT07086339