NCT00137956

Brief Summary

The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

First QC Date

August 26, 2005

Last Update Submit

August 14, 2009

Conditions

EmphysemaChronic Obstructive Pulmonary Disease

Keywords

Endobronchial ValveEndobronchial Valve ProcedureEBVEBV ProcedureEndobronchial Lung Volume ReductionLung Volume Reduction

Outcome Measures

Primary Outcomes (1)

  • The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days

Secondary Outcomes (1)

  • The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.

Interventions

Emphasys Endobronchial Valve (EBV) Device and ProcedureDEVICE

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior lung transplant, lung volume reduction surgery (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 of the lung for carbon monoxide (DLCO) \< 20% predicted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

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    PMID: 7792372BACKGROUND

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    PMID: 1405801BACKGROUND

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    PMID: 12505859BACKGROUND

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Robert Kaplan, PhD

    UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

December 1, 2004

Last Updated

August 18, 2009

Record last verified: 2009-08