Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung

Not Applicable

Recruiting

• Conditions: Respiratory - Chronic obstructive pulmonary disease; Chronic obstructive pulmonary disease (COPD)

• Registration Number: ACTRN12610000190000
• Lead Sponsor: Portaero, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in 1 second (FEV1) of greater than or equal to 12% (FEV1>= 12%) from baseline[Baseline, 3 and 6 Months after intervention];Decrease in Saint George's Respiratory Questionnaire (SGRQ)(total) of 4 points or more from baseline[Baseline, 3 and 6 Months after intervention]

Secondary Outcome Measures

Name	Time	Method
ung function status by Forced Vital Capacity (FVC), Residual Volume (RV), Residual Volume to Total Lung Capacity ratio (RV/TLC)[Baseline, 3 and 6 Months after intervention];Lung Volume Computerized Tomography (CT) Scan results[Baseline, 3 and 6 Months after intervention];Exercise tolerance as measured by 6 minute walk test (6MWT) and Cycle Ergometry test[Baseline, 3 and 6 Months after intervention];Dyspnea evaluation by Modified Medical Research Council (mMRC) Dyspnea scores[Baseline, 3 and 6 Months after intervention];Quality of Life as assesssed by EQ-5D questionnaire[Baseline, 3 and 6 Months after intervention]