Clinical Accuracy Study of the AViTA Infrared Ear Thermometer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Objective:
研究概览
简要总结
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.
This is a single day, single visit study. After obtaining informed consent, the investigator will conduct the study related screening procedures like medical/medication history, demographic data (date of birth, gender, race, ethnicity, weight, height and body mass index etc.) recording and physical examination. Participants who fulfil all the inclusion/exclusion criteria will be eligible for the study.
The participant will be allowed to stabilize for a period of twenty (20) minutes before temperature measurements, especially if they come from a different environmental temperature than that in which the thermometers are stored.
Timing will be monitored as part of the data collection. The sequence of use of 3 devices will be as per randomization schedule. The measurement of body temperature of each participant will be performed by keeping a minimum 1-minute interval between thermometer readings. Each thermometer will be held at the opening of ear canal for a period of 5 to 10 seconds. The measurement of body temperature of each device will be recorded once only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant will be eligible for inclusion in this study only if all of the following criteria meets.
- •Children of age more than 1 month to less than 18 years or Male and female participants of age 18 years or above
- •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.
- •Participants LAR Parents or Legal Guardian who are willing and able to comply with the protocol requirement for the duration of the study examinations.
- •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.
排除标准
- •Participant will not be eligible for inclusion in this study if any of the following criteria meets:
- •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)
- •Participant with an acute life-threatening infection
- •Participant with an anatomical abnormality that affects temperature measurement
- •Participant with blood or drainage in the external ear canal
- •Participant wearing a hearing aid (Participant may be included if the hearing aid is removed 20 minutes prior to testing and throughout the examination)
- •Participant who has used ear drops within 8 hours prior to testing
- •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.)
- •Participant with traumatic injuries
- •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.
结局指标
主要结局
Primary Objective:
时间窗: Baseline
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.
时间窗: Baseline
次要结局
- NA(NA)
研究者
Dr Vaibhav Kothari
Navneet Memorial Hospital Sushrusha