CompletedNot Applicable

Clinical Accuracy Study for Infrared Thermometer

China155 participantsStarted 2026-01-09

Plain-language summary

A clinical study will be conducted on the Infrared Thermometers to verify whether its clinical accuracy (clinical bias, limits of agreement, and clinical repeatability) meets the standard requirements.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 0-1 year, 1-5 years, or \>5 years, regardless of gender;
. The subject or/and their guardian consents and signs the Informed Consent Form.

Exclusion criteria

. Premature infants with a gestational age of less than 37 weeks and low-birth-weight infants (birth weight less than 2.5kg); this item applies only to subjects aged 0-3 months;
. Life-threatening acute infections;
. Subjects who have taken a bath, sponge bath, applied hot/cold compresses, eaten, cried restlessly, or engaged in strenuous exercise within 30 minutes before the trial;
. Subjects who have taken antipyretics within 180 minutes before the start of the measurement;
. Other situations deemed inappropriate for participation in this study by the investigator, such as receiving immunization within 7 days before the test.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical bias and limits of agreement

Timeframe: Baseline

Clinical repeatability

Timeframe: Baseline

Trial details

NCT IDNCT07728916

SponsorSuzhou Care-Real Medical Technology Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-09

View on ClinicalTrials.gov More Temperature Change, Body trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 0-1 year, 1-5 years, or \>5 years, regardless of gender;
. The subject or/and their guardian consents and signs the Informed Consent Form.

Exclusion criteria

. Premature infants with a gestational age of less than 37 weeks and low-birth-weight infants (birth weight less than 2.5kg); this item applies only to subjects aged 0-3 months;
. Life-threatening acute infections;
. Subjects who have taken a bath, sponge bath, applied hot/cold compresses, eaten, cried restlessly, or engaged in strenuous exercise within 30 minutes before the trial;
. Subjects who have taken antipyretics within 180 minutes before the start of the measurement;
. Other situations deemed inappropriate for participation in this study by the investigator, such as receiving immunization within 7 days before the test.