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
  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:


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 April 15, 2014