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Therapeutic Areas: Pulmonary/Respiratory Diseases
Disease Category: Emphysema
Trial Information
The IBV Trial . An Investigational treatment 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,
Sandra Calloway, Study Coordinator
Cardiothoracic Surgery ,University of Alabama, Birmingham
709 19th Street South ZRB 739
Birmingham AL
Phone: 205-975-4437
EMail: sandra.calloway@ccu.uab.edu
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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