Health Condition 1: A99- Unspecified viral hemorrhagic fever
Conditions
Interventions
Intervention1: The NexTemp GO F oral thermometer: The NexTemp GO Oral Thermometer is a nonelectronic disposable medical device intended
for singleuse sublingual application.
Control Intervention1: NI
Sponsors
Medical Indicators Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 20 to 30 MIN | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3.To determine the proportion of subjects classified as febrile by each device, based on a predefined fever threshold for example temperature equal to or higher than 37.5 C 4.To compare the time required to obtain a temperature reading using each device. 5.To collect usability ratings from healthcare personnel and adult subjects regarding comfort and ease of use of each thermometer. 6.To perform a safety assessment, including any reported adverse events related to device use discomfort during measurement, handling difficulties. 7.To document and evaluate any device malfunctions or operational issues encountered during the study.Timepoint: 20 to 30 MIN | — |
Countries
India
Contacts
Public ContactMrs. Amandeep Kaur Sehmi
Bioexcel Lifescience and Research LLP, Nagpur
Outcome results
None listed