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Procedure
1 for Emphysema (EASE Trial)
Phase 3
Waitlist Available
Led By Joel D. Cooper, MD, FACS, FRCS
Research Sponsored by Broncus Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
Stopped smoking at least 8 weeks before entering the trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
EASE Trial 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.
Eligible Conditions
- Emphysema
EASE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEASE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
modified Medical Research Council (mMRC) score (breathlessness)
Secondary outcome measures
6-minute walk (6MW)
Cycle Ergometry
Forced Expiratory Volume in 1 second (FEV1)
+6 moreEASE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy during which up to six Exhale drug-eluting stents are placed in the lungs
Group II: 2Placebo Group1 Intervention
subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed
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Who is running the clinical trial?
Broncus TechnologiesLead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Emphysema
60 Patients Enrolled for Emphysema
Joel D. Cooper, MD, FACS, FRCSPrincipal Investigator
Gerhard W. Sybrecht, Prof. Dr. med.Principal InvestigatorUniversitätskliniken des Saarlandes
Frequently Asked Questions
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