[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 December 19, 2007. Last Updated on December 4, 2009 History of Changes

Sponsor:	[Redacted]
Information provided by:	[Redacted]
ClinicalTrials.gov Identifier:	NCT00578513

Responsible Party:	[Redacted]
ClinicalTrials.gov Identifier:	NCT00578513 History of Changes
Other Study ID Numbers:	202-U-004
Study First Received:	December 19, 2007
Last Updated:	December 4, 2009
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 09, 2012