Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
Sponsored by Olympus Corporation of the Americas
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Candidates have mostly upper lobe, severe emphysema.
- Must be able to participate in standard exercise testing.
- Willing to abstain from cigarette smoking for 4 months prior and during the entire trial.
- Willing to participate in a randomized, blinded study and complete the required follow-up visits during the study period.
- Willing to participate in multiple visits to a medical center for health assessment tests.
- Willing to have a minimum of one overnight stay in the hospital.
Exclusion Criteria
- Evidence of another co-existing major medical disease.
- Unable to tolerate, flexible bronchoscopy procedures.
- Active asthma, chronic bronchitis.
- Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
- Has had prior lung volume reduction surgery.