Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-07 @ 12:50 PM
Study NCT ID:
NCT03147534
Status:
WITHDRAWN
Last Update Posted:
2021-01-14
First Post:
2017-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thermometry in Canada for Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000285', 'term': 'Administration, Rectal'}], 'ancestors': [{'id': 'D058956', 'term': 'Administration, Mucosal'}, {'id': 'D000287', 'term': 'Administration, Topical'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-22', 'size': 7982123, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-12T08:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not able to recruit patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature measurements using "Welch Allyn" (oral/rectal), Covidien (tympanic) and ARC InstaTempMD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.', 'timeFrame': 'Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.', 'description': 'Compare the compendia thermometers in each age range to the InstaTemp MD to determine average clinical bias.'}], 'secondaryOutcomes': [{'measure': 'Mean Comparison Analysis. Temperature measurements using "Welch Allyn" (oral/recta.), Covidien (tympanic) and ARC InstaTemp MD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.', 'timeFrame': 'Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.', 'description': 'To determine the precision of the InstaTemp MD compared to the compendia thermometers based on three consecutive measurements with each thermometer.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy', 'Febrile Illness']}, 'descriptionModule': {'briefSummary': 'Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques presently in use for measuring temperature in infants and children in a Canadian clinical setting.', 'detailedDescription': "This study is designed as a multi-center study. This study will involve collecting temperatures on patients using the InstaTemp MD® device and the traditional method used in the clinical setting. Reliability and agreement of the InstaTemp MD® will be compared to the current Canadian Paediatric Society's definitely recommended methods of temperature measurement in certain age cohorts of infants and children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children Age 1 month to ≤ 10 years old\n* Male or female\n* 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\n* 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\n\nExclusion Criteria:\n\n* Subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures\n* Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes.\n* Subjects with signs or recent history of inflammation or infection of the forehead or at the reference clinical test site.\n* Subjects currently using cooling blankets or fans\n* 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.\n* Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead)\n* Subjects currently alcohol intoxicated\n* Subjects with documented illicit durg use in the previous 5 days\n* Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading\n* Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child\n* Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days."}, 'identificationModule': {'nctId': 'NCT03147534', 'acronym': 'CIT-CRCP', 'briefTitle': 'Comparison of Thermometry in Canada for Pediatrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'ARC Devices'}, 'officialTitle': 'Comparison of the InstaTemp MD® Infrared Thermometer With Standard Thermometry in Canadian Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'CIT-CRCP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Children Age 1 month to 2 years', 'description': 'Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.', 'interventionNames': ['Device: InstaTemp MD', 'Device: "Welch Allyn", rectal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Children > 2 to 5 years', 'description': 'Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.', 'interventionNames': ['Device: InstaTemp MD', 'Device: "Welch Allyn", rectal', 'Device: Covidien, tympanic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Children > 5 to ≤ 10 years', 'description': 'Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.', 'interventionNames': ['Device: InstaTemp MD', 'Device: "Welch Allyn", oral', 'Device: Covidien, tympanic']}], 'interventions': [{'name': 'InstaTemp MD', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Children > 2 to 5 years', 'Children > 5 to ≤ 10 years', 'Children Age 1 month to 2 years']}, {'name': '"Welch Allyn", rectal', 'type': 'DEVICE', 'description': 'The "Welch Allyn" rectal thermometer is intended to measure human body temperature.', 'armGroupLabels': ['Children > 2 to 5 years', 'Children Age 1 month to 2 years']}, {'name': '"Welch Allyn", oral', 'type': 'DEVICE', 'description': 'The "Welch Allyn" oral thermometer is intended to measure human body temperature.', 'armGroupLabels': ['Children > 5 to ≤ 10 years']}, {'name': 'Covidien, tympanic', 'type': 'DEVICE', 'description': 'The Covidien tympanic thermometer is intended to measure human body temperature.', 'armGroupLabels': ['Children > 2 to 5 years', 'Children > 5 to ≤ 10 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K2G1W2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Center for Pediatric Excellence', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H7P 0H9', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': "Agoo Children's Health and Wellness Centre", 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}], 'overallOfficials': [{'name': 'Judy van Stralen, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Pediatric Excellence'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARC Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}