Endobronchial Valve for Emphysema Palliation Trial (VENT)
Condition: Chronic Obstructive Pulmonary Disease; Emphysema
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 3

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 pulmonary rehabilitation) in patients with heterogeneous emphysema.
    

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 expel air and efficiently absorb oxygen. As this chronic condition inexorably
      progresses, the diseased, hyperinflated areas of the lung eventually fill the chest cavity,
      leaving less and less volume available for the viable lung tissue.

      Lung volume reduction surgery (LVRS) has been shown to offer relief to patients suffering
      from emphysema when other treatment options fail. Researchers have continued to refine both
      technique and patient selection in order to improve outcomes. The objective of lung volume
      reduction is to eliminate dysfunctional, over-inflated regions of lung. Results similar to
      surgical removal have been obtained by plication (folding) and stapling without tissue
      removal. These results suggest that isolation of the dysfunctional lung region can achieve
      similar results to tissue removal.

      The paradoxical effect of improving lung function by removing (or isolating) lung tissue
      demonstrates that breathlessness due to emphysema is a function of mechanical inefficiencies
      in addition to loss of gas-transfer surface area and other physiological mechanisms. At least
      in some patients, the mechanical compromise is the primary cause of their pulmonary
      incapacitation and these patients can benefit by addressing their inability to effectively
      inhale and exhale. Because LVRS reduces trapped gas, others have speculated that results
      similar to LVRS could be achieved bronchoscopically by reducing the volume of the
      hyperinflated regions with, or without, atelectasis.

      Emphasys has developed a bronchoscopic approach to block inspiratory airflow into targeted,
      hyperinflated regions of the lung, while permitting exhaled gas to escape. This approach may
      lead to lung volume reduction and provide some of the clinical benefits of LVRS without the
      high risks and costs associated with such an invasive surgical procedure.

      Comparison:

      The primary object of this study is to assess the safety and efficacy of the Emphasys
      Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to medical
      management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.
    

Intervention name(s): Emphasys Endobronchial Valve and procedure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endobronchial Valve (EBV) Procedure; Bronchoscopic Lung Volume Reduction