Clinical Evaluation of NIR (Non-Invasive Infrared) Thermo... | NCT00760422

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

NCT00760422

Sponsor

Medisim Ltd

Status

Completed

Last Update Posted

Apr 20, 2012Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Elevated Temperature

Interventions

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2012

Last Update Posted Date

Apr 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With fever			Device: NIR
Without fever			Device: NIR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIR	Device	Thermometer	With fever Without fever

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

500 patients from both genders, 0-18 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Children's Medical Center of Israel		Petah Tikva		49202	Israel

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided