[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.

Study NCT00850109 Information provided by Breathe Technologies, Inc.

First Received: February 22, 2009 Last Updated: February 23, 2009 History of Changes

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	February 22, 2009
Last Updated Date	February 23, 2009
Start Date ^†	February 2009
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00850109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	[Trial of device that is not approved or cleared by the U.S. FDA]
Official Title ^†
Brief Summary
Detailed Description
Study Phase
Study Type ^†
Study Design ^†
Condition ^†
Intervention ^†
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Withheld
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility Criteria ^†
Gender
Ages
Accepts Healthy Volunteers
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00850109
Responsible Party	Angela King, Breathe Technologies, Inc.
Secondary IDs ^††
Study Sponsor ^†	Breathe Technologies, Inc.
Collaborators ^††
Investigators ^†
Information Provided By	Breathe Technologies, Inc.
Verification Date
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.