European Clinical Study
Spiration® is sponsoring an IBV Valve System Study in Europe. The objective of this study is to augment the initial clinical data used to obtain the CE Mark with data from a randomized, blinded study.
The first patients were enrolled in the European study in April 2007. Investigators are actively recruiting patients for the study. The study is open to men and women age 40 to 74 who have been diagnosed with predominantly upper lobe emphysema and shortness of breath with exertion. Eligible patients are able to participate in pulmonary function and standardized exercise tests, have not smoked for four months and are willing to not smoke during the trial. Additional criteria must be met for participation in the study.
For information regarding the ongoing clinical study in Europe, send an email to: EuropeanClinicalStudy@spiration.com.
European Clinical Study Sites
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Austria Innsbruck Austria: Landeskrankenhaus Investigator: Dr. Christian Geltner Belgium Brussels Belgium: CHU Saint Pierre Investigator: Dr. Vincent Ninane Germany Hannover Germany: Medizinische Hochschule Hannover Investigators: Professor Tobias Welte and Dr. Jens Gottlieb Spain Barcelona Spain: Bellvitge Hospital Investigators: Dr. Antoni Rosell and Dr. Pablo Diaz Jimenez Pamplona Spain: Clinica Universitaria de Navarra Investigators: Dr. Luis Seijo and Dr. Javier Zulueta United Kingdom Preston, Lancashire, United Kingdom: Royal Preston Hospital/Lancashire Teaching Hospitals Investigator: Dr. M. Munavvar |