Temperature Measurement Using a Non Invasive Device | NCT01584401

Studies
Temperature Measurement Using a Non Invasive Device

NCT01584401

Sponsor

Medisim Ltd

Status

Unknown status

Last Update Posted

Apr 25, 2012Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Body Temperature Measurement

Interventions

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 22, 2012

First Submission Date that Met QC Criteria

Apr 24, 2012

First Posted Date

Apr 25, 2012Estimated

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 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Main study objectives:

To compare the temperature measured using Medisim's thermometers to the temperature measured using mercury or equivalent reference thermometers.
To develop more accurate algorithms for measuring on the forehead as well as behind the ear.
To test the difference between various forehead measurement locations in order to allow more convenient measuring that is not depended on the exact location.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients arriving to the emergency room
A signed consent by the patient or the guardian.

Exclusion Criteria:

The medical staff decides that patient is not allowed to participate.
The patient refuses to participate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Non-blinded, randomized study format. Study population includes 500 patients at all ages and from both genders.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yehezkel Weissman, Proffessor	Schneider Children's Medical Center, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Children's Medical Center of Israel		Petah Tikva		49100	Israel

Type	Date	Date Unknown
Release	Apr 10, 2013
Reset	Jun 26, 2013