Emphysema Clinical Trial
— BTSAOfficial title:
Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of
bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.
Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral
bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an
inflammatory airway and parenchymal injury and consequently fibrotic response resulting in
LVR;
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age 40-75 unlimited sex. 20 subjects 2. COPD, GOLD 3-4 (global obstructive lung disease). 3. CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes. 4. Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%. 5. 6 minute walking distance > 140 meters. Exclusion Criteria: 1. Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%. 2. Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%. 3. Pulmonary hypertension> 45 mmHg, according to the Echo Test. 4. . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years. 5. Pregnancy - |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Assaf Harofeh Medical Center | Beer Yaakov |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary function improvemnt | Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD . | 6 months | Yes |
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