None listed
Conditions
Brief summary
The primary objective of this study is to evaluate and determine the types of complications and benefits from the transthoracic pneumonostomy procedure in patients with severe emphysema (homogeneous). The results from this study will provide the profile for safety and feasibility of use of the pneumonostomy device system and support subsequnt trials with larger number of patients.
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 up to 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 (computed tomography) scan consistent with severe emphysema grade of greater than or equal to 2 (per NETT, National Emphysema Treatment Trial) involving both ipsilateral upper and lower lobes 2. Airflow obstruction as evidenced by FEV1/FVC ratio (Forced Expiratory Volume in the first second/Forced Vital Capacity ratio) < 70% post-bronchodilator 3. Patients with FEV1 > 20% and < 45% of predicted post bronchodilator 4. Patient with hyperinflation defined as a) RV (Residual Volume) > 150% of predicted post bronchodilator b) TLC (Total Lung Capacity) > 100% post bronchodilator
Exclusion criteria
1. PaCO2 (pressure of carbon dioxide) > 60mm Hg breathing room air 2. 6 minute walk test distance (6MWT) < 140m after completing pulmonary rehabilitation 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. BMI (body mass index) < 17 or > 31 6. Patient with uncontrolled hypertension, defined as blood pressure > 200/110 mmHg 7. Patient with severe pulmonary hypertension defined as RVESP (right ventricular end systolic pressure) = 49 mmHg by echocardiography at Screening (or documented RVSP (right ventricular systolic pressure) > 45 mmHg by right heart catheterization) 8. Patient with myocardial infarction within 6 months, LVEF (left ventricular ejection fraction) < 45% or any other cardiac condition / arrhythmia that poses an anesthetic risk 9. Patient with bleeding risk, i.e., abnormal clotting, anticoagulants that cannot be ceased peri-operatively, or thrombocytopenia (platelet count < 100 X 103/µL ) 10. Patient with known a-1 antitrypsin deficiency 11. Patient who underwent previous ipsilateral LVRS (lung volume reduction surgery), lobectomy or pleural surgery. 12. Patient has giant bulla that occupy more than >1/3 volume of lung 13. Patient has known lung cancer or pulmonary nodule(s) that require investigation 14. Patient is currently being treated with high dose corticosteroids defined as > 10mg/day prednisone or equivalent 15. Female patient with positive HCG (human chorionic gonadotropin) pregnancy test at Screening.
Outcome results
None listed