Temperature Change, BodyNCT07728916
Clinical Accuracy Study for Infrared Thermometer
A study testing Infrared Thermometer and Electronic Thermometer in people with Temperature Change, Body, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Infrared Thermometer and Electronic Thermometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2026to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Infrared Thermometer, Electronic Thermometer
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared ThermometerDevice
The test data are based on the data displayed by the infrared thermometer developed and manufactured by CONTEC Medical Systems Co., Ltd.
Electronic ThermometerDevice
The test data is based on the data displayed by the electronic thermometer developed and manufactured by joytech healthcare Co. Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Infrared Thermometer | Experimental | Infrared Thermometer is produced by Contec Medical Systems Co., Ltd. Receives: Device: Infrared Thermometer |
| Electronic Thermometer | Other | Electronic Thermometer produced by JOYTECH HEALTHCARE CO. LTD. Receives: Device: Electronic Thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline
Secondary outcomes (2)
Device performance evaluation
It is evaluated by the investigator using the test device, including operational satisfaction, working stability, and performance failures.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start9 Jan 2026
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728916
- Sponsor's protocol ID
- TP600-CIP
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Accuracy Study for Infrared Thermometer
- ClinicalTrials.gov ID
- NCT07728916
- Acronym / sponsor ID
- TP600-CIP
- Conditions
- Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.University, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrared Thermometer | Experimental | Device: Infrared ThermometerInfrared Thermometer is produced by Contec Medical Systems Co., Ltd. |
| Electronic Thermometer | Other | Device: Electronic ThermometerElectronic Thermometer produced by JOYTECH HEALTHCARE CO. LTD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared ThermometerThe test data are based on the data displayed by the infrared thermometer developed and manufactured by CONTEC Medical Systems Co., Ltd. | Device | Infrared Thermometer |
| Electronic ThermometerThe test data is based on the data displayed by the electronic thermometer developed and manufactured by joytech healthcare Co. Ltd. | Device | Electronic Thermometer |
Primary outcome
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.
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
2 secondary outcomes
Device performance evaluation
Time frame: Baseline
Device defects
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared Thermometer and Electronic Thermometer in people with Temperature Change, Body, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical bias and limits of agreement (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.