[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.

First Received on May 16, 2008. Last Updated on March 23, 2010 History of Changes

Sponsor:	[Redacted]
Information provided by:	[Redacted]
ClinicalTrials.gov Identifier:	NCT00680251

Responsible Party:	[Redacted]
ClinicalTrials.gov Identifier:	NCT00680251 History of Changes
Other Study ID Numbers:	272-U-009
Study First Received:	May 16, 2008
Last Updated:	March 23, 2010
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Austria: Agency for Health and Food Safety; Austria: Ethikkommission; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on February 09, 2012