Clinical Evaluation of NIR (Non-Invasive Infrared) Thermometer Performance

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Medisim Ltd

ClinicalTrials.gov Identifier:

NCT00760422

First received: September 25, 2008

Last updated: April 19, 2012

Last verified: August 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 25, 2008
Last Updated Date	April 19, 2012
Start Date ^ICMJE	December 2008
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00760422 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	Clinical Evaluation of NIR (Non-Invasive Infrared) Thermometer Performance
Official Title ^ICMJE	Not Provided
Brief Summary	The study is conducted in order to evaluate the performance of the NIT thrmometer by comparing the predictive measurement to equilibrium measurement and to make a final tuning to the thermometer algorithm.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	500 patients from both genders, 0-18 years old
Condition ^ICMJE	Elevated Temperature
Intervention ^ICMJE	Device: NIR Thermometer
Study Group/Cohort (s)	With fever Intervention: Device: NIR Without fever Intervention: Device: NIR
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	Completed
Estimated Enrollment ^ICMJE	500
Completion Date	March 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Children 0-18 years old, with or without fever that arrive at the unit of emergency medicine in Schneider medical center. An informed Consent was signed by the patient or his guardian. Exclusion Criteria: The medical stuff decides that the patient can't participate.
Gender	Both
Ages	up to 18 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00760422
Other Study ID Numbers ^ICMJE	26-115-25
Has Data Monitoring Committee	Yes
Responsible Party	Medisim Ltd
Study Sponsor ^ICMJE	Medisim Ltd
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medisim Ltd
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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