Status:
COMPLETED
AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema
Lead Sponsor:
Aeris Therapeutics
Conditions:
Pulmonary Emphysema
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage I...
Detailed Description
Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most com...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC\<70% predicted, FEV1 of \<50% predicted, TLC \> 100% predicted, and RV \> 135% predicted.
- Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
- Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
Exclusion
- \-
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01181466
Start Date
August 1 2010
End Date
May 1 2011
Last Update
October 21 2011
Active Locations (2)
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1
The Soroka Medical Center
Beersheba, Israel
2
The Rabin Medical Center
Petah Tikva, Israel