Study:
A Randomized, Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale® Drug-Eluting Stent in Homogeneous Emphysema Subjects With Severe Hyperinflation
Rationale:
n/a
Purpose:
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.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Emphysema |
Device: Exhale® Drug-Eluting Stent
Device: Sham control |
Phase 3 |
Verified by
Broncus Technologies
January, 2011
Sponsored by: Broncus Technologies
Information provided by: Broncus Technologies
ClinicalTrials.gov identifier: NCT00391612
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Joel D. Cooper, MD, FACS, FRCS., Principal Investigator
Gerhard W. Sybrecht, Prof. Dr. med.., Principal Investigator