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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
  Purpose

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.


Condition Intervention
Elevated Temperature
 Device: NIR

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Fever
U.S. FDA Resources

Further study details as provided by Medisim Ltd:

Estimated Enrollment: 500
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
With fever Device: NIR
Thermometer
Without fever Device: NIR
Thermometer

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

500 patients from both genders, 0-18 years old

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760422

Locations
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Sponsors and Collaborators
Medisim Ltd
  More Information

No publications provided

Responsible Party: Medisim Ltd
ClinicalTrials.gov Identifier: NCT00760422     History of Changes
Other Study ID Numbers: 26-115-25
Study First Received: September 25, 2008
Last Updated: April 19, 2012
Health Authority: Israel:Institutional Review Board

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013