Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

Completed · Not applicable

Conditions studied: Emphysema, COPD

In brief

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.

Key facts

Study ID

NCT00475007

Run by

Olympus Corporation of the Americas

People needed

277

Starts

2007-09-01

Expected to finish

2017-08-01

Last updated by the study team

2018-04-17

Who can join

Age: 40 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Kaiser Permanente Medical Center — Los Angeles, California, United States
• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• Mission Internal Medicine Group — Mission Viejo, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California San Diego — San Diego, California, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Emory HealthCare — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Alexian Brothers Hospital Network — Elk Grove Village, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Pulmonary and Critical Care Associates of Baltimore — Baltimore, Maryland, United States
• Health Partners Research Foundation/Regions Hospital — Saint Paul, Minnesota, United States
• Pulmonary and Allergy Associates — Summit, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Akron General Medical Center — Akron, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oklahoma State University — Tulsa, Oklahoma, United States
• Kaiser Permanente Northwest — Portland, Oregon, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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