Status:
UNKNOWN
Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Emphysema
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation. Description: Patients w...
Detailed Description
Inclusion criteria: 1. Age 40-75 unlimited sex. 20 subjects 2. chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease). 3. CT scan of lung and included high resolutio...
Eligibility Criteria
Inclusion
- Age 40-75 unlimited sex. 20 subjects
- COPD, GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- TLC\> 110%, RV\> 150%, DLCO \<80%,FEV1: 15-45%.
- 6 minute walking distance \> 140 meters.
- \-
Exclusion
- Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) \<40%.
- Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension\> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
- Pregnancy -
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01920321
Start Date
February 1 2013
End Date
December 1 2014
Last Update
August 12 2013
Active Locations (1)
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1
Assaf Harofeh Medical Center
Beer Yaakov, Israel, 70300