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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

CPR-01377

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
40 to 74 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.

What are the participation requirements?

Yes

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.

No

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.