Status:
COMPLETED
Endobronchial Valve for Emphysema Palliation Trial (VENT)
Lead Sponsor:
Emphasys Medical
Conditions:
Chronic Obstructive Pulmonary Disease
Emphysema
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulm...
Detailed Description
Background: Emphysema, caused primarily by smoking, is characterized by the gradual, irreversible breakdown of tissue and loss of elastic recoil within the lungs, causing them to lose the ability to ...
Eligibility Criteria
Inclusion
- Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
- Forced expiratory volume in 1 second (FEV1) \< 45% predicted
- Total lung capacity (TLC) \> 100% predicted
- Residual volume (RV) \> 150% predicted
- Post rehabilitation 6 minute walk test \> 140m
- Non-smoking for 4 months
Exclusion
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
- History of recurrent respiratory infections
- Evidence of large bullae (\>30% of either lung) in a non-target lobe
- FEV1 \< 15% predicted
- Diffusing capacity for carbon monoxide (DLCO) \< 20% predicted
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00129584
Start Date
January 1 2004
Last Update
August 18 2009
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