Endobronchial Valve for Emphysema Palliation Trial (VENT)

This study has been completed.
Sponsor:
Information provided by:
Emphasys Medical
ClinicalTrials.gov Identifier:
NCT00129584
First received: August 10, 2005
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Emphysema
Procedure: Emphasys Endobronchial Valve and procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endobronchial Valve for Emphysema Palliation Trial (VENT)

Resource links provided by NLM:


Further study details as provided by Emphasys Medical:

Primary Outcome Measures:
  • Pulmonary function testing at various time points through one year
  • Exercise tolerance at various time points through one year
  • Major complications at various time points through one year

Secondary Outcome Measures:
  • Pulmonary function testing at various time points through one year
  • Quality of life measures at various time points through one year
  • Other adverse event rates at various time points through one year

Estimated Enrollment: 270
Study Start Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129584

Sponsors and Collaborators
Emphasys Medical
Investigators
Principal Investigator: Frank C Sciurba, MD University of Pittsburgh
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00129584     History of Changes
Other Study ID Numbers: 630-0001
Study First Received: August 10, 2005
Last Updated: August 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Emphasys Medical:
Endobronchial Valve (EBV) Procedure
Bronchoscopic Lung Volume Reduction

Additional relevant MeSH terms:
Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014