None listed
Conditions
Brief summary
This is the second trial to evaluate the safety and performance of the Portaero Pneumostoma System in patients with severe emphysema and hyperinflation of the lung.
Interventions
The surgical device kit of the Portaero System creates a pneumonostomy channel through a minimally-invasive transthoracic surgical approach. The procedure is a single session event that takes approximately 1 hour to complete.
Sponsors
Portaero, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. CT scan consistent with severe emphysema grade >= 2 (per National Emphysema Treatment Trial (NETT) ) involving both ipsilateral upper and lower lobes 2. Airflow obstruction as evidenced by Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity ratio (FEV1/FVC)< 70% post-bronchodilator 3. Patients with FEV1>20% and <45% of predicted post bronchodilator 4. Patient with hyperinflation defined as: a. Residual Volume (RV)> 150% of predicted post bronchodilator b. Total Lung Capacity (TLC)>100% post bronchodilator 5. Arterial blood or arterialized blood gas results of: a. Partial Pressure of Oxygen in Arterial Blood (PaO2) >= 45 mmHg breathing room air b. Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)< 60 mmHg breathing room air 6. Transfer Factor of Carbon Monoxide (TLco) > 20% predicted
Exclusion criteria
1. Six minute walk test distance (6MWT) < 140m after completing pulmonary rehabilitation 2. Clinically significant daily sputum production or bronchiectasis 3. Patient experienced 3 or more exacerbations of COPD requiring hospitalization over previous 12 months 4. Patient is currently using domiciliary noninvasive ventilation (NIV) with the exception of continuous positive airway pressure (CPAP) or biphasic positive airway pressure for the treatment of obstructive sleep apnea (OSA) 5. Patient with chest infection within 30 days prior to procedure (NOTE: After meeting eligibility and patient develops chest infection with 30 days prior to procedure, patient must wait a minimum of 45 days or until infection is resolved.) 6. Body Mass Index (BMI) < 17 or >31 7. Patient with uncontrolled hypertension, defined as blood pressure > 200/110 mmHg 8. Patient with Cerebrovascular accident (CVA) within last 12 months 9. Patient with severe pulmonary hypertention defined as Right Ventricular End Systolic Pressure (RVESP)>= 49 mmHg by echocardiography at Screening (or documented Right Ventricular Systolic Pressure (RVSP)> 45 mmHg by Right Heart Catheterization (RHC)) 10. Patient with Myocardial Infarction (MI) within 6 months, Left Ventricular Ejection Fraction (LVEF)<45% or any other cardiac condition/arrhythmia that posses an anesthetic risk 11. Patient with bleeding risk, i.e., abnormal clotting, anticoagulants that cannot be ceased peri-operatively, or thrombocytopenia (platelet count < 100 X 10^3/micro liters) 12. Patient with known Alpha-1 antitrypsin deficiency 13. Patient who underwent previous ipsilateral Lung Volume Resection Surgery (LVRS), lobectomy or pleural surgery. 14. Patient has giant bulla that occupy more than >1/3 volume of lung 15. Patient has known lung cancer or pulmonary nodule(s) that require investigation 16. Patient is currently being treated with high dose corticosteroids (defined as > 10mg/day prednisone or equivalent) for a total of more than 30 days within the past 2 months
Outcome results
None listed