Emphysema Emphysema
Conditions
Interventions
The investigational product is the Pulmair Medical Implantable Artificial Bronchus 50 Flex, model number PS-5001, with a 50 mm nominal length when released in air. The IAB is packaged with a delivery
both components are provided sterile. Both the IAB 50 Flex and delivery device are single-use devices. The Depth Tool (PS-1000) is an accessory required to aid in proper IAB placement. The Depth Tool
Sponsors
Pulmair
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Signed Informed ConsentDiagnosis of severe emphysema (GOLD 3 or 4) who have received optimized medical and pharmaceuitical managementAt least 22-years of age18 = BMI = 356-minute walk Distance of between 100 – and 400 meters Stable disease with less than 10-mg prednisone (or equivalent) dailyNon-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).FEV1 between 15% and 45% of predicted value at baseline examFEV1/FVC <70%Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 10% 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 criteria
Exclusion criteria: Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatmenta-1 Antitrypsin deficiencyWomen of child-bearing potentialMore than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening Any COPD exacerbations requiring hospitalization within 6-weeks of planned interventionTwo or more instances of pneumonia episodes requiring hospitalization in the last year prior to screeningClinically significant mucus production or chronic bronchitisMyocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screeningPrior lung transplant, LVRS, bullectomy or lobectomy Prior endoscopic lung volume reduction (ELVR). Individuals with failed ELVR procedures with endobronchial valves are eligible only if the device(s) was removed at least 3-months prior to consent and no significant atelectasis, stenosis, or granulation tissue is present.Clinically significant bronchiectasisUnable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-daysUncontrolled 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 procedureSuspected malignant pulmonary nodule or other lung cancerHRCT 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 lungInsufficient landmarks to evaluate the CT study using the software as it is intendedAll lobes are less than 25% parenchyma diseased (< -950 HU). Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implantTLC < 100% predicted at screeningDLCO < 15% or of predicted value at screeningPaCO2 > 50 mm Hg at screeningPaO2 < 45 mm Hg in room air at screeningPlasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.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.Unable to tolerate bronchoscopic procedures.Adults under legal protection.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence of respiratory serious adverse events related to the device or procedure (SADEs) through the 90-day endpoint. The endpoint is descriptive only. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are multiple secondary endpoints: all other serious adverse device events (SADEs) occurring at any time during the study; all efficacy endpoints, measured as changes from baseline to 90-days after the last IAB implant procedure, involving pulmonary function, exercise tolerance, dyspnea burden and occurrence. | — |
Countries
France, Netherlands
Contacts
Public ContactM Lima
Pulmair
Outcome results
None listed