Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

August 14, 2009 updated by: Emphasys Medical
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. In the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time.

Questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. In 1993, the Department of Health and Human Services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. The panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. These analyses require preference-weighted measures of health-related quality of life. Such measures are needed in order to adjust survival time for health-related quality of life.

Study Type

Interventional

Enrollment

270

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emphasys Medical

Investigators

  • Principal Investigator: Robert Kaplan, PhD, UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 14, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 630-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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