Clinical Accuracy Study for Infrared Thermometer

NCT07728916 | Completed

• 1 other identifier: TP600-CIP
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (2)

• Clinical bias and limits of agreement

  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.

  Baseline

• Clinical repeatability

  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

  Baseline

Secondary Outcomes (2)

• Device performance evaluation

  Baseline

• Device defects

  Baseline

Study Arms (2)

Infrared Thermometer

EXPERIMENTAL

Infrared Thermometer is produced by Contec Medical Systems Co., Ltd.

Device: Infrared Thermometer

Electronic Thermometer

OTHER

Electronic Thermometer produced by JOYTECH HEALTHCARE CO. LTD.

Device: Electronic Thermometer

Interventions

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.

Infrared Thermometer

Electronic Thermometer DEVICE

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

Electronic Thermometer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Care-Real Medical Technology Co., Ltd.: lead

Study Sites (1)

Handan Maternal and Child Health Hospital

Handan, Hebei, China

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 27, 2026
• Study Start: January 9, 2026
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)