Status:
UNKNOWN
EASE Trial: Exhale Airway Stents for Emphysema
Lead Sponsor:
Broncus Technologies
Conditions:
Emphysema
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief 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 hyper...
Detailed Description
Over 3 million people in the United States and tens of millions more throughout the world live with emphysema, a chronic, progressive, irreversible disease of the lungs. The hallmark of emphysema is h...
Eligibility Criteria
Inclusion
- High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
- Stopped smoking at least 8 weeks before entering the trial.
- Post-bronchodilator RV/TLC ≥ 0.65.
- Post-bronchodilator Forced Expiratory Volume (FEV1) ≤ 50% or FEV1 \< 1 liter.
- Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
- Patient has undergone supervised pulmonary rehabilitation of 16-20 sessions over 6-10 weeks.
Exclusion
- Change in FEV1 \> 20% pre- and post- bronchodilator measurements or \> 200 ml if post-bronchodilator FEV1 \< 1 liter.
- Respiratory infections requiring 3 or more hospitalizations in past year.
- Inability to walk \> 140 meters (150 yards) in 6 minutes.
- Previous lung volume reduction surgery (LVRS) or lobectomy.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00391612
Start Date
May 1 2006
End Date
December 1 2013
Last Update
January 12 2011
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
2
UCSF-Fresno
Fresno, California, United States, 93701
3
University of Southern California
Los Angeles, California, United States, 90033
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048