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CompletedNCT07728916Updated Jul 27, 2026

Clinical Accuracy Study for Infrared Thermometer

An interventional study of Infrared Thermometer and Electronic Thermometer in Temperature Change, Body, sponsored by Suzhou Care-Real Medical Technology Co., Ltd.. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Suzhou Care-Real Medical Technology Co., Ltd. · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2026, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
155
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Temperature Change, Body
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 155 is above the median of 40 across 68 interventional studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

This is the only study on the registry with Suzhou Care-Real Medical Technology Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Life-threatening acute infections;
  3. 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;
  4. Subjects who have taken antipyretics within 180 minutes before the start of the measurement;
  5. Other situations deemed inappropriate for participation in this study by the investigator, such as receiving immunization within 7 days before the test.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    Infrared Thermometer

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

    Device: Infrared Thermometer

  • Other
    Electronic Thermometer

    Electronic Thermometer produced by JOYTECH HEALTHCARE CO. LTD.

    Device: Electronic Thermometer

Interventions

  • DeviceInfrared Thermometer

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

  • DeviceElectronic Thermometer

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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

    Time frame: Baseline

Secondary outcomes

  1. Device performance evaluation

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

    Time frame: Baseline

  2. Device defects

    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.

    Time frame: Baseline

07

Study locations

1 site
  • Handan Maternal and Child Health Hospital
    Handan, Hebei, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Apr 2026, 3 months.

Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 3 months is below that.

Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Jul 27, 2026
StartActual
Jan 9, 2026
Primary completionActual
Apr 9, 2026
CompletionActual
Apr 9, 2026
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07728916
Lead sponsor
Suzhou Care-Real Medical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Jan 9, 2026
Primary completion
Apr 9, 2026
Completion
Apr 9, 2026
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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