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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760422
First Posted: September 26, 2008
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medisim Ltd
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760422


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

Responsible Party: Medisim Ltd
ClinicalTrials.gov Identifier: NCT00760422     History of Changes
Other Study ID Numbers: 26-115-25
First Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: April 20, 2012
Last Verified: August 2008

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