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EASE Trial: Exhale Airway Stents for Emphysema

NCT00391612 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2011-01-12

No results posted yet for this study

Summary

This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.

Conditions

  • Emphysema

Interventions

DEVICE

Exhale® Drug-Eluting Stent

Bronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours

DEVICE

Sham control

5-10 minute bronchoscopic procedure in which the lungs are examined and a bronchial lavage is performed; the bronchoscope is then retracted to a point above the carina and below the vocal folds for the remained of the time; total procedure time is about 1-2 hours

Sponsors & Collaborators

  • Broncus Technologies

    lead INDUSTRY

Principal Investigators

  • Joel D. Cooper, MD, FACS, FRCS

  • Gerhard W. Sybrecht, Prof. Dr. med. · Universitätskliniken des Saarlandes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-10-31
Completion
2013-12-31

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00391612 on ClinicalTrials.gov