Status:
COMPLETED
European Multi-center Post Market Study of the IBV Valve System
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-74 years
Phase:
NA
Brief Summary
The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy proced...
Detailed Description
The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bro...
Eligibility Criteria
Inclusion
- Between 40 and 74 years of age
- Predominantly upper lobe emphysema and severe dyspnea
- Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
- Physical ability to participate in the study by performing a 6-minute walk distance of \> 140m
- No cigarette smoking for 4 months and willing to abstain throughout the study
- Severe airflow obstruction defined by FEV1 45% of predicted
- Severe hyperinflation defined by: TLC \> 100% of predicted and RV \> 150% of predicted
Exclusion
- Between 70 and 74 years of age and an FEV1 or DLCO \< 20% of predicted
- Severe gas exchange abnormalities
- Major medical disease that will limit evaluation, participation or follow-up
- Active asthma component to their disease
- Giant bulla (\> 1/3 volume of lung)
- Severe pulmonary hypertension
- Requirement for \> 6L02 to keep saturation \> 90% with exercise
- Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00880724
Start Date
March 1 2007
End Date
June 1 2010
Last Update
May 9 2017
Active Locations (7)
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1
Landeskrankenhaus
Innsbruck, Austria
2
CHU Saint Pierre
Brussels, Belgium
3
Medizinische Hochschule Hannover
Hanover, Germany
4
Spedali Civili di Brescia
Brescia, Italy