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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01097824
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 Posted : April 2, 2010
Last Update Posted : April 2, 2010
Sponsor:
Information provided by:
[Redacted]

Tracking Information
First Submitted Date  ICMJE March 31, 2010
First Posted Date  ICMJE April 2, 2010
Last Update Posted Date April 2, 2010
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE [Trial of device that is not approved or cleared by the U.S. FDA]
Official Title  ICMJE [Trial of device that is not approved or cleared by the U.S. FDA]
Brief Summary Not Provided
Detailed Description Not Provided
Study Type  ICMJE Not Provided
Study Phase Not Provided
Study Design  ICMJE Not Provided
Condition  ICMJE Not Provided
Intervention  ICMJE Not Provided
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withheld
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Not Provided
Sex/Gender Not Provided
Ages Not Provided
Accepts Healthy Volunteers Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01097824
Other Study ID Numbers  ICMJE CP-0508
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party [Redacted]
Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account [Redacted]
Verification Date Not Provided