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: July 14, 2008
Last updated: July 15, 2008
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT00716313     History of Changes
Other Study ID Numbers: VS-01 
Study First Received: July 14, 2008
Last Updated: July 15, 2008
Health Authority: Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Institutional Review Board processed this record on December 05, 2016

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