Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: AViTA Infrared Ear Thermometer (Test Device): The AViTA Infrared Ear Thermometer is a hand-held, battery-powered, non-sterile, reusable, infrared thermometer that converts a user s ear
Sponsors
eInfoChips Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participant will be eligible for inclusion in this study only if all of the following criteria meets. 1. Children of age more than 1 month to less than 18 years or Male and female participants of age 18 years or above 2. Participants with an afebrile condition 97 degree Fahrenheit or 36.1 Celsius to 99 degree Fahrenheit or 37.2 Celsius or Participants with a febrile condition 99.5 degree Fahrenheit or 37.5 Celsius or above. 3. Participants LAR Parents or Legal Guardian who are willing and able to comply with the protocol requirement for the duration of the study examinations. 4. Participants, LAR, Parents or Legal Guardian who are willing to provide informed consent or assent form participants 7 to 17 years of age to participate in the study.
Exclusion criteria
Exclusion criteria: Participant will not be eligible for inclusion in this study if any of the following criteria meets: 1. Pre-term new-born babies (babies born before 37 weeks of gestation) or small-for-gestational age newborn babies (newborn baby, born at 37 weeks or later, with a weight below the 10th percentile for new-born babies of the same gestational age) 2. Participant with an acute life-threatening infection 3. Participant with an anatomical abnormality that affects temperature measurement 4. Participant with blood or drainage in the external ear canal 5. Participant wearing a hearing aid (Participant may be included if the hearing aid is removed 20 minutes prior to testing and throughout the examination) 6. Participant who has used ear drops within 8 hours prior to testing 7. Participant with ear diseases (such as ear infection, acute or inflammatory condition such as swimmer s ear, an obstruction in which the tympanic membrane cannot be visualized or excess cerumen build-up.) 8. Participant with traumatic injuries 9. Any other condition that, in the investigator s judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To gather temperature measurements from study participants in an adaptive manner with the AViTA Infrared Ear Thermometer, in conjunction with temperature measurements of the study participants taken with the Gold Standard / reference device, the Welch Allyn Braun ThermoScan PRO 6000 Ear Thermometer, for the purposes of research and development of the AViTA Infrared Ear Thermometer.Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mangesh Shende
Akshar Global Clinical Research Private Limited
Outcome results
None listed