Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

[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.
Sponsor:
Information provided by:
[Redacted]
ClinicalTrials.gov Identifier:
NCT00448812
First received: March 16, 2007
Last updated: February 11, 2010
Last verified: NA

Responsible Party: [Redacted]
ClinicalTrials.gov Identifier: NCT00448812     History of Changes
Other Study ID Numbers: 05-01
Study First Received: March 16, 2007
Last Updated: February 11, 2010
Health Authority: Canada: Health Canada
United Kingdom: Research Ethics Committee
Brazil: National Committee of Ethics in Research
Denmark: Ethics Committee

ClinicalTrials.gov processed this record on November 24, 2014

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