A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Single Lobe Treatment of Severe Emphysema
Trial status: Open for Enrollment
Why is this study being done?
This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the IBV Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.
The IBV Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
Who is eligible to participate?
- Subject has severe and heterogeneous emphysema with severe dyspnea
- Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
- Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m
- Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
- Pulmonary Function Testing Results (PFT's) demonstrate:
- FEV1 ≤ 45% of predicted
- RV ≥ 150% of predicted
- TLC ≥ 100% of predicted
- Patient has a BMI < 15 kg/m2 or > 35 kg/m2
- Arterial Blood Gas Level (ABG) indicates:
- PCO2 > 50 mm Hg
- PO2 < 45 mm Hg on room air
- Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency
- Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
- Subject has an active asthma (>15 mg of prednisone daily)
- Giant bulla (> 1/3 volume of lung)
- Pulmonary hypertension
- Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections