Trial Information

Summary: The IBV® Valve Trial A research study for people suffering from Emphysema.

A clinical trial is underway utilizing an investigational device intended to improve the over all health status and quality of life for people living with emphysema.

This is a randomized blinded study, which means that participants will not know which group they will be assigned to, the valve treatment group or the control group. The participants assigned to the valve treatment group will have an investigational medical device implanted in their lungs with an instrument known as a bronchoscope. This procedure is done without an incision. These small, umbrella shaped valves are designed to redirect airflow to healthier areas of the lungs. At the completion of the 6 month study and the follow up visits, participants in the control group will be eligible to be evaluated for valve treatment.

Inclusion

• Ages 40 to 74
• 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 up to 4 day-long visits to a medical center for health assessment tests.
• Willing to have a minimum of one overnight stay in the hospital

Exclusion

• 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

For more information about the IBV® Valve Trial, visit www.emphysematrial.com or,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.