A prospective, interventional, open-label, non-randomized, within-subjects comparative clinical study to evaluate the performance, safety, and usability of the NexTemp® Single-Use Thermometer against standard clinical thermometers (GoodBaby Infrared non-contact Thermometer, The Braun ThermoScan 4 Tympanic ear thermometer, and Welch A oral digital thermometer) in real-world clinical settings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- 1.To evaluate the accuracy of the NexTemp® Go Thermometer by comparing temperature readings with a reference thermometer. To assess the difference in body temperature readings (°C) between each device per subject.
研究概览
简要总结
**Study Title:**A prospective, interventional, open-label, non-randomized, within-subjects comparative clinical study to evaluate the performance, safety, and usability of the NexTemp® Single-Use Thermometer against standard clinical thermometers (GoodBaby Infrared non-contact Thermometer, The Braun ThermoScan 4 Tympanic ear thermometer, and Welch A oral digital thermometer) in real-world clinical settings.
This is a prospective, interventional, open-label, non-randomized, within-subjects comparative clinical study designed to evaluate the performance, safety, and usability of the NexTemp® Single-Use Thermometer as the primary investigational device, compared with three reference thermometers— GoodBaby Infrared non-contact Thermometer, The Braun ThermoScan 4 Tympanic ear thermometer, and Welch A oral digital thermometer — in real-world clinical settings. A total of 111 subjects, aged 4 to 85 years, will be enrolled. Each subject will participate in a single visit, during which body temperature will be measured sequentially using all four thermometers during a routine vital sign assessment. The duration of each measurement session will be approximately 5 to 10 minutes per subject. The sequence of device use will be standardized across all participants, and appropriate time intervals will be observed between measurements to reduce variability. Written informed consent (and assent where applicable) will be obtained from all participants or their legal guardians prior to
participation. Data collected will include temperature readings from each device, time to obtain readings, user feedback from clinical personnel (and adult participants, where relevant), and any adverse events, device malfunctions, or usability concerns.
Body temperature measurements will be performed sequentially using:
1. The Infra-Red (waiting 10-12 minutes will allow the skin temp to adjust to ambient and not represent the performance during normal standalone conditions when IR is the only device being used)
2. Tympanic (membrane temp is also impacted by external conditions, not as much as skin)
3. Oral (Welsh Allyn) and record time in the mouth to compare to Go
4. Oral (NXT Go) and record time in the mouth to confirm 10 seconds in the heat pocket.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 4.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects aged between 4 to 85 years.
- •2.Subjects undergoing routine body temperature measurement as part of standard medical care.
- •3.Subjects who are clinically stable and able to undergo non-invasive temperature measurement.
- •4.Subjects (or their legal guardians) who provide written informed consent (and assent, where applicable) prior to study participation.
- •5.Willing and able to comply with the study procedures.
排除标准
- •1.Subjects with underlying medical conditions that could interfere with accurate temperature 2.measurement (eg severe infections, hypothermia or skin disorders at the measurement site 3.Recent exposure to external temperature influences such as hot/cold beverage consumption physical exertion or sweating within the last 30 minutes 4.Individuals with ear infections deformities or obstructions specific to tympanic thermometer use Subjects currently taking antipyretic medications or undergoing treatments likely to affect body temperature within the past 4 hours 5.Subjects who are unable to cooperate with the measurement procedure eg crying infants 6.cognitively impaired adults without supervision Participation in another clinical study that could interfere with study outcomes 7.Any other condition that, in the investigators opinion, may render the subject unsuitable for participation.
结局指标
主要结局
1.To evaluate the accuracy of the NexTemp® Go Thermometer by comparing temperature readings with a reference thermometer. To assess the difference in body temperature readings (°C) between each device per subject.
时间窗: 20 to 30 MIN
次要结局
- 1.To assess the ease of use and handling characteristics of each thermometer as reported by clinical users.(2.To evaluate the performance of the thermometers under various environmental and patient conditions.)
研究者
Dr Sudhir Bhatnagar
Abhinav Multispeciality Hospital Nagpur