Emphasys Endobronchial Valve and procedure in Chronic Obstructive Pulmonary Disease and Emphysema - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Emphasys Endobronchial Valve and procedure

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.

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, 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

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
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

Outcome Measure
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

Collaborators and Investigators

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

Sponsor

Emphasys Medical

Investigators

Principal Investigator: Frank C Sciurba, MD, University of Pittsburgh Medical Center

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

January 1, 2004

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria