Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-02-01
2018-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Children Age 1 month to 2 years
Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.
InstaTemp MD
The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.
"Welch Allyn", rectal
The "Welch Allyn" rectal thermometer is intended to measure human body temperature.
Children > 2 to 5 years
Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.
InstaTemp MD
The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.
"Welch Allyn", rectal
The "Welch Allyn" rectal thermometer is intended to measure human body temperature.
Covidien, tympanic
The Covidien tympanic thermometer is intended to measure human body temperature.
Children > 5 to ≤ 10 years
Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.
InstaTemp MD
The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.
"Welch Allyn", oral
The "Welch Allyn" oral thermometer is intended to measure human body temperature.
Covidien, tympanic
The Covidien tympanic thermometer is intended to measure human body temperature.
Interventions
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InstaTemp MD
The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.
"Welch Allyn", rectal
The "Welch Allyn" rectal thermometer is intended to measure human body temperature.
"Welch Allyn", oral
The "Welch Allyn" oral thermometer is intended to measure human body temperature.
Covidien, tympanic
The Covidien tympanic thermometer is intended to measure human body temperature.
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed
* Subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent
Exclusion Criteria
* Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes.
* Subjects with signs or recent history of inflammation or infection of the forehead or at the reference clinical test site.
* Subjects currently using cooling blankets or fans
* Subjects with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for InstaTemp MD and definitive comparator (e.g. rectal or oral) measurements.
* Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead)
* Subjects currently alcohol intoxicated
* Subjects with documented illicit durg use in the previous 5 days
* Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading
* Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child
* Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.
1 Month
10 Years
ALL
Yes
Sponsors
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ARC Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Judy van Stralen, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Center for Pediatric Excellence
Locations
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Center for Pediatric Excellence
Ottawa, Ontario, Canada
Agoo Children's Health and Wellness Centre
Laval, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CIT-CRCP-001
Identifier Type: -
Identifier Source: org_study_id
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