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

Elevated Temperature Clinical Trial

— NIR  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760422
• Other study ID #: 26-115-25
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: April 19, 2012
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: August 2008
• Source: Medisim Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Elevated Temperature
• Fever

Intervention

Device:
• NIR
Thermometer

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Medisim Ltd

Country where clinical trial is conducted

Israel,