Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

[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.
Information provided by:
[Redacted] Identifier:
First received: August 5, 2011
Last updated: February 8, 2012
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT01412112     History of Changes
Other Study ID Numbers: 3010-ACL  R44HD055019 
Study First Received: August 5, 2011
Last Updated: February 8, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board processed this record on January 14, 2017

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