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Completed

NCT Number: NCT07728916

Clinical Accuracy Study for Infrared Thermometer

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.

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Key information

Conditions

Temperature Change, Body Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Handan Maternal and Child Health Hospital

Handan, Hebei, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infrared Thermometer

Device

The test data are based on the data displayed by the infrared thermometer developed and manufactured by CONTEC Medical Systems Co., Ltd.

Electronic Thermometer

Device

The test data is based on the data displayed by the electronic thermometer developed and manufactured by joytech healthcare Co. Ltd.

Primary outcomes

  1. Clinical bias and limits of agreement

    Time frame: Baseline

    Mean difference between OUTPUT TEMPERATURES of a CLINICAL THERMOMETER and a REFERENCE CLINICAL THERMOMETER for the intended REFERENCE BODY SITE with specified LIMITS OF AGREEMENT when measured from selected group of subjects.

  2. Clinical repeatability

    Time frame: Baseline

    Pooled standard deviation (over a selected group of subjects) of changes in multiple OUTPUT TEMPERATURES taken from the same subject at the same MEASURING SITE with the same CLINICAL THERMOMETER by the same OPERATOR within a relatively short time

Secondary outcomes

  1. Device performance evaluation

    Time frame: Baseline

    It is evaluated by the investigator using the test device, including operational satisfaction, working stability, and performance failures.

  2. Device defects

    Time frame: Baseline

    Device defects refer to unreasonable risks that may endanger human health and safety when medical devices are used normally during clinical trials, such as label errors, quality issues, and malfunctions. During the trial, closely observe the performance and safety of the test device, and monitor whether the test device has quality problems, malfunctions, or other defects, and whether these problems endanger the health or safety of the subjects.

Sponsors and collaborators

Lead sponsor

Suzhou Care-Real Medical Technology Co., Ltd.

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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