[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:

NCT00447590

First received: March 14, 2007

Last updated: December 7, 2012

Last verified: NA

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2007
Last Updated Date	December 7, 2012
Start Date ^ICMJE	February 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE (submitted: March 14, 2007)	Percent of subjects who attain clinically successful weight loss at one year post LAP-BAND implantation.
Change History	Complete list of historical versions of study NCT00447590 on ClinicalTrials.gov Archive Site
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 Arm (s)	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
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Not Provided
Gender	Not Provided
Ages	Not Provided
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00447590
Other Study ID Numbers ^ICMJE	LBA-001
Has Data Monitoring Committee	Not Provided
Responsible Party	[Redacted]
Study Sponsor ^ICMJE	[Redacted]
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	[Redacted]
Verification Date	Not Provided
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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