Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT03452020
Status:
UNKNOWN
Last Update Posted:
2018-03-02
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-06-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body temperature measurement', 'timeFrame': 'a period of no more than 12 minutes'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Temperature Measurement']}, 'descriptionModule': {'briefSummary': 'Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.\n\nThe patients will be divided into 3 study groups by age:\n\nGroup 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years\n\nThe following temperature measurements will be taken:\n\n1. Three temperature measurements using the Tyto thermometer\n2. Temperature measurement using the standard of care\n3. Three temperature measurements using the predicate device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, of any age\n2. Subject or Parent/Guardian: able to communicate with study personnel;\n3. Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent\n4. Subject or Parent/Guardian willing to comply with study procedures\n\nExclusion Criteria:\n\n1. Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.\n2. Subject or legal guardian unwilling to sign informed consent form\n3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).\n4. Subjects currently using cooling blankets, ice on their forehead or fans.\n5. Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.\n6. Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.\n7. Subjects with documented illicit drug use or alcoholic intoxication\n8. Those participating in a clinical trial of an investigational medicinal product\n9. Carriers of multi drug resistant bacteria\n10. Pregnancy\n11. CTAS score of 1-2'}, 'identificationModule': {'nctId': 'NCT03452020', 'briefTitle': 'Evaluation of the Tyto Thermometer When Used in Clinical Care Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tyto Care Ltd'}, 'officialTitle': 'Evaluation of the Tyto Thermometer When Used in Clinical Care Setting', 'orgStudyIdInfo': {'id': '790-00038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tyto Thermometer, SoC Thermometer, Predicate IR Th', 'description': 'All the study participants undergo temperature measurements with:\n\n1. Tyto Thermometer\n2. Standard of Care thermometer\n3. Predicate IR thermometer', 'interventionNames': ['Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer']}], 'interventions': [{'name': 'Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer', 'type': 'DEVICE', 'description': 'Temperature measurements using the Tyto thermometer, the standard of care thermometer and the predicate thermometer', 'armGroupLabels': ['Tyto Thermometer, SoC Thermometer, Predicate IR Th']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Assaf Sharabi, MD', 'role': 'CONTACT', 'email': 'AssafSh@clalit.org.il', 'phone': '972544747245'}], 'facility': "Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Stella Raizelman Perry, MSc', 'role': 'CONTACT', 'email': 'stellar@tytocare.com', 'phone': '972.72.221.0750'}, {'name': 'Ofer Tzadik, Eng', 'role': 'CONTACT', 'email': 'ofert@tytocare.com', 'phone': '972524761210'}], 'overallOfficials': [{'name': 'Yehezkel Waisman, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tyto Care Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}