NL-OMON30701
Completed
Phase 3
A randomized, double-blind study to evaluate the safety and effectiveness of the Exhale Drug-eluting stent in homogeneous emphysema subjects with severe hyperinflation, the EASE - study. & Local ammendment: Protocol revision to evaluate the ExhaleUltraNeedle in the EASE study. - EASE - study
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Broncus Technologies Inc.
- Enrollment
- 15
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Homogenous emphysema on CT\-thorax
- •Post\-bronchodilitator \<50% pred or \<1 liter
- •Post\-bronchodilitator FEV1/FVC ratio \<70%
- •Post\-bronchodilitator RV/TLC ratio \>0,65
Exclusion Criteria
- •Recurrent pulmonary infections and bronchiectasis
- •Cardiovasculair pathology
- •PaCO2 \>60mmHg
- •Alpha\-1 antitrypsin deficiency
Investigators
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