Pilot Study of the Spiration IBV™ System
The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a selected portion of the lung, producing a reduction in lung volume, which may improve pulmonary function in patients with emphysema.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of the Spiration IBV™ System|
- The primary endpoint of this study is to evaluate the safety of the device, during deployment and short-term implantation for a period of up to 3 months.
- The secondary endpoint is to estimate the effectiveness achieved after 1 and 3 months of use.
|Study Start Date:||December 2003|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
This pilot study is an open enrollment, prospective study with each subject serving as their own control. The sponsor may attempt to include the data from this study in the statistical analysis of the pivotal study. This proposal shall be evaluated at the conclusion of the pilot study.
PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study. In this initial pilot study, eligible subjects will have severe, heterogeneous, predominantly upper lobe emphysema, as defined by the American Thoracic Society (ATS) 1 and the NETT Research Group.2
These subjects also will be patients who have been screened as potential candidates for LVRS, but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS.2 Patients also will be able to tolerate a flexible bronchoscopy procedure.
Patients who have been screened and accepted for a lung transplant procedure or LVRS, and are currently registered or scheduled for such a procedure, are not eligible for enrollment in this pilot study.
Patients with an FEV1 < 20% predicted and either homogeneous emphysema or DLCO < 20% will be excluded from enrollment in this pilot study.3
Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System. Up to 15 clinical centers will be selected to enroll and treat subjects.
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Georgia|
|Emory Health Care|
|Atlanta, Georgia, United States, 30322|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|United States, New York|
|North Shore - Long Island Jewish Health System|
|Long Island, New York, United States, 11030|
|Columbia University Medical Center|
|New York City, New York, United States, 10032|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27110|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|