Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-12 @ 2:30 AM
Study NCT ID:
NCT03758157
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2018-11-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Accuracy of the welloStationX
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allen.heller@welloinc.com', 'phone': '469-522-5200', 'title': 'Alan C. Heller', 'organization': 'Wello, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One day.', 'eventGroups': [{'id': 'EG000', 'title': 'Temperature Measurement', 'description': 'Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.\n\nwelloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.\n\nSureTemp: SureTemp is an oral thermometer to measure human body skin temperature.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Agreement Through Clinical Bias Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Temperature Measurement', 'description': 'Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'Agreement through clinical bias evaluation was calculated as the Mean Bias ± Standard Deviation (SD) by subtracting the first output measurement recorded with the welloStationX thermometer (DUT) from the corresponding output measurement recorded with the Welch Allyn SureTemp oral thermometer for each subject, and then calculating the Mean Bias ± SD of the biases.', 'unitOfMeasure': 'degrees Farehheit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Repeatability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Temperature Measurement', 'description': 'Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.062', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one day', 'description': 'Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.', 'unitOfMeasure': 'degrees Farehheit', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'welloStationX Automated Non-Contact Thermometer', 'description': 'welloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Temperature Measurement', 'description': 'welloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.\n\nSureTemp: SureTemp is an oral thermometer to measure human body skin temperature.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.78', 'spread': '16.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'febrility', 'classes': [{'categories': [{'title': 'febrile subjects (temperature >=99.5 deg. C)', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'afebrile subjects (temperature < 99.5 deg. C)', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-21', 'size': 470092, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-14T18:15', 'hasProtocol': True}, {'date': '2018-11-28', 'size': 624600, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-14T18:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2018-11-27', 'resultsFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-14', 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Agreement Through Clinical Bias Evaluation', 'timeFrame': 'one day', 'description': 'Agreement through clinical bias evaluation was calculated as the Mean Bias ± Standard Deviation (SD) by subtracting the first output measurement recorded with the welloStationX thermometer (DUT) from the corresponding output measurement recorded with the Welch Allyn SureTemp oral thermometer for each subject, and then calculating the Mean Bias ± SD of the biases.'}], 'secondaryOutcomes': [{'measure': 'Clinical Repeatability', 'timeFrame': 'one day', 'description': 'Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fever']}, 'descriptionModule': {'briefSummary': 'This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.', 'detailedDescription': "Traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. Non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. Additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people.\n\nThis study is to evaluate the clinical accuracy of the welloStationX, a non-contact thermometer by comparing its measurements with that of the gold standard Welch Allyn SureTemp oral thermometer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected from amongst non-profit clinical sites and through social media posts for subjects to come to a test site or to be evaluated in his or her own home in the widespread Dallas/Fort Worth area.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female.\n* 5 years and up.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test.\n* immunization within seven days of the test'}, 'identificationModule': {'nctId': 'NCT03758157', 'briefTitle': 'Clinical Accuracy of the welloStationX', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wello Inc.'}, 'officialTitle': 'welloStationX Determination of Clinical Accuracy', 'orgStudyIdInfo': {'id': 'Wello_X'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Temperature Measurement', 'description': 'Each subject will have his or her temperature measured by both the welloStationX Automated Non-Contact Thermometer and the Welch Allyn SureTemp Oral Thermometer.', 'interventionNames': ['Diagnostic Test: welloStationX', 'Diagnostic Test: SureTemp']}], 'interventions': [{'name': 'welloStationX', 'type': 'DIAGNOSTIC_TEST', 'description': 'welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.', 'armGroupLabels': ['Temperature Measurement']}, {'name': 'SureTemp', 'type': 'DIAGNOSTIC_TEST', 'description': 'SureTemp is an oral thermometer to measure human body skin temperature.', 'armGroupLabels': ['Temperature Measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Agape Clinic', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Alan C Heller', 'role': 'STUDY_CHAIR', 'affiliation': 'Wello Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wello Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}