Franciscan Research Center at St. Joseph Medical Center in Tacoma is participating as a clinical trial site evaluating a minimally invasive device for the treatment of severe emphysema.
Eligible patients are being recruited to participate in this study.
The new device, called the IBV® Valve System, is manufactured by Spiration, Inc. in Redmond, Wash.
The study is open to men and women ages 40 to 74 that have been diagnosed with predominantly upper lobe emphysema and severe dyspnea (shortness of breath). Eligible patients are:
· Able to participate in pulmonary function and standardized exercise tests
· Have not smoked for four months
· Are willing to not smoke during the trial
· Will commit to at least four visits to a medical center for health assessment tests. Additional criteria must also be met for participation in the study.
The IBV® Valve Trial is a randomized, prospective, double-blind clinical trial that will enroll as many as 500 people at up to 40 sites across the nation. Patients enrolled in the control arm of the study will be eligible to receive treatment with the IBV® Valve System after completion of the six-month study.
Safety and effectiveness data from this trial will be submitted to the U.S. Food and Drug Administration (FDA) for approval to market the device in the United States.
For more information or to apply to participate in this trial, contact Christine Biljan at the Franciscan Research Center. The office number is (253) 426-6882; the email address is christinebiljan@FHShealth.org