Transthoracic Pneumonostomy System for Severe Emphysema
- Conditions
- Chronic obstructive pulmonary disease (COPD)Respiratory - Chronic obstructive pulmonary disease
- Registration Number
- ACTRN12608000408381
- Lead Sponsor
- Portaero, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method