All Patients Who Require Monitoring of Their Temperatures Over the Age of 19NCT07432269
A Prospective, Controlled, Single-Center Confirmatory Study to Evaluate the Accuracy and Safety of Core Temperature Measurement Using the XST600 Electronic Thermometer Compared to the 3M SpotOn Thermometer in Adult Patients
An observational study of All Patients Who Require Monitoring of Their Temperatures Over the Age of 19, run by Yonsei University.
Trial summary
The body temperature measured by the skin is easily affected by the measurement environment such as temperature or humidity, and in some cases, the difference from the central body temperature is particularly large. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- All Patients Who Require Monitoring of Their Temperatures Over the Age of 19
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age and Gender: Men and women aged between 19 and 80 years. Clinical Requirement: Patients who need to monitor their body temperature in the operating room or intensive care unit at Severance Hospital. Voluntary Consent: Subjects (or their legal representatives) who have received a detailed explanation of the study and have voluntarily provided written informed consent. Baseline Temperature: Only subjects with a confirmed core temperature of 36.1 or higher (as measured by a Reference Clinical Thermometer) will be included.
Who may be able to join
- Males and females aged 19 to 80 years.
- Patients requiring continuous temperature monitoring in the Operating Room or Intensive Care Unit.
- Subjects (or their legal representatives) who have been fully informed about the study and have voluntarily provided written informed consent.
Who cannot join
- Skin Conditions: Presence or high risk of skin diseases, wounds, infections, or allergic reactions (e.g., rash) at the application site (forehead).
- Medication Interference: * Current use of drugs that may interfere with clinical trial results, such as barbiturates (sedatives/hypnotics), thyroid preparations, or antipsychotic drugs (per ISO 80601-2-56).
- o Administration of antipyretics within the last 120 minutes or immunization within the last month (per ISO 80601-2-56).
- Medical History: Any underlying medical condition that may significantly impact the interpretation of the clinical results.
- Investigator Discretion: Any individual deemed inappropriate for participation by the principal investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The body temperature measured by the skin is easily affected by the measurement environment such as temperature or humidity, and in some cases, the difference from the central body temperature is particularly large. Therefore, there has been an attempt to develop a new method of measuring skin body temperature to predict the central body temperature by measuring body temperature in the skin. The purpose of this study is to evaluate the effectiveness and safety of the core temperature measured using this medical device by comparing the accuracy of the body temperature measured through the XST600 electronic thermometer applying the HF technology developed by Chois Technology with the body temperature measured by the Gold Standard 3M Bair Hugger Temperature Monitoring System Model 370. - Number of target subjects: 117 in total - Basis for calculation: This clinical trial is an corroborating clinical trial to confirm the clinical accuracy and effectiveness of the test equipment (XST600), so it is set based on the requirements of ISO 80601-2-56 (the "Medical Device Standard" 50. Electronic thermometer). 1. Total number of target subjects: 117 (105 + 10%) * At least 105 participants are required in accordance with ISO 80601-2-56:2017, and 117 participants are targeted by applying the normal research dropout rate of 10%. * If the research procedure is completed in 105 participants without dropping out, the study is terminated. ① Normal body temperature subject: 82 (73 participants + 10%): Those with a core temperature of 36.1℃ (10) or more and 38.0℃ or less when measured by RCT. * If the research procedure is completed in 73 participants without dropping out, the study is terminated. ② Number of subjects with heating: 35 (32 participants + 10%): Subjects with a core temperature of 38.0℃ or higher when measured by RCT * According to ISO 80601-2-56, the maximum number of subjects with heating is 32, by applying the standard that should not exceed 30%, and the target is 35, by applying the normal research dropout rate of 10%. * If the research procedure is completed without dropping out of only 32 subjects, the study is terminated.
Read the detailed description
This study is designed to simultaneously apply both the test and control devices to each subject. All subjects (N = 105) will have the sensors attached at the same anatomical position; therefore, no group assignment (randomization) will be conducted.
- Simultaneous Measurement: Both the Bair Hugger™ Model 370 and XST600 will measure temperature concurrently.
- Target Core Temperature: Only subjects with a core temperature of 36.1 or higher (as measured by Reference Clinical Thermometer) will be included.
Inclusion Criteria
- Males and females aged 19 to 80 years.
- Patients requiring continuous temperature monitoring in the Operating Room or Intensive Care Unit.
- Subjects (or their legal representatives) who have been fully informed about the study and have voluntarily provided written informed consent.
Exclusion Criteria
- Skin Conditions: Presence or high risk of skin diseases, wounds, infections, or allergic reactions (e.g., rash) at the application site (forehead).
- Medication Interference: * Current use of drugs that may interfere with clinical trial results, such as barbiturates (sedatives/hypnotics), thyroid preparations, or antipsychotic drugs (per ISO 80601-2-56).
- Administration of antipyretics within the last 120 minutes or immunization within the last month (per ISO 80601-2-56).
- Medical History: Any underlying medical condition that may significantly impact the interpretation of the clinical results.
- Investigator Discretion: Any individual deemed inappropriate for participation by the principal investigator.
Measurement Methods \& Data Acquisition
- Bair Hugger™ Temperature Monitoring System Model 370
- Setup: Connect the sensor to the cable connector, ensuring the tab is fully inserted and aligned.
- Stabilization: Allow a minimum of 5 minutes for the temperature to stabilize.
- Recording: Once stable, press 'Start' in the app. Data will be recorded for a minimum of 25 minutes post-stabilization.
- Frequency: Measurements will be recorded at 1-minute intervals.
- XST600 Measurement Method
- Recording: Once the measured temperature stabilizes (minimum 5 minutes), press the 'Start' button in the app.
- Duration: The recording duration shall be at least 25 minutes following the stabilization period.
- Automation: Upon clicking 'Start', data is automatically saved at 1-second intervals. The process concludes when the 'End' button is clicked.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal body temperature subjects | This study is designed to simultaneously apply both the test and control devices to each subject. All subjects (N = 105) will have the sensors attached at the same anatomical position; therefore, no group assignment (randomization) will be conducted | |
| Subjects with fever | This study is designed to simultaneously apply both the test and control devices to each subject. All subjects (N = 105) will have the sensors attached at the same anatomical position; therefore, no group assignment (randomization) will be conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature measured with a Bair Hugger Temperature Monitoring System Model 370 thermometer
Body temperature measured with a Bair Hugger Temperature Monitoring System Model 370 thermomete
Measured: When the measured body temperature of the subject enters the stabilization phase (at least 5 minutes), the body temperature data is recorded, and the test time is at least 25 minutes after the stabilization phase.
Secondary outcomes (1)
Body temperature measured with an XST600 thermometer
Body temperature measured with an XST600 thermometer
Measured: When the measured body temperature of the subject enters the stabilization phase (at least 5 minutes), the body temperature data is recorded, and the test time is at least 25 minutes after the stabilization phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 May 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Patients Who Require Monitoring of Their Temperatures Over the Age of 19Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432269
- Sponsor's protocol ID
- 1-2025-0073
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled, Single-Center Confirmatory Study to Evaluate the Accuracy and Safety of Core Temperature Measurement Using the XST600 Electronic Thermometer Compared to the 3M SpotOn Thermometer in Adult Patients
- ClinicalTrials.gov ID
- NCT07432269
- Acronym / sponsor ID
- 1-2025-0073
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 25 Feb 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.
The body temperature measured by the skin is easily affected by the measurement environment such as temperature or humidity, and in some cases, the difference from the central body temperature is particularly large. Therefore, there has been an attempt to develop a new method of measuring skin body temperature to predict the central body temperature by measuring body temperature in the skin. The purpose of this study is to evaluate the effectiveness and safety of the core temperature measured using this medical device by comparing the accuracy of the body temperature measured through the XST600 electronic thermometer applying the HF technology developed by Chois Technology with the body temperature measured by the Gold Standard 3M Bair Hugger Temperature Monitoring System Model 370. - Number of target subjects: 117 in total - Basis for calculation: This clinical trial is an corroborating clinical trial to confirm the clinical accuracy and effectiveness of the test equipment (XST600), so it is set based on the requirements of ISO 80601-2-56 (the "Medical Device Standard" 50. Electronic thermometer). 1. Total number of target subjects: 117 (105 + 10%) * At least 105 participants are required in accordance with ISO 80601-2-56:2017, and 117 participants are targeted by applying the normal research dropout rate of 10%. * If the research procedure is completed in 105 participants without dropping out, the study is terminated. ① Normal body temperature subject: 82 (73 participants + 10%): Those with a core temperature of 36.1℃ (10) or more and 38.0℃ or less when measured by RCT. * If the research procedure is completed in 73 participants without dropping out, the study is terminated. ② Number of subjects with heating: 35 (32 participants + 10%): Subjects with a core temperature of 38.0℃ or higher when measured by RCT * According to ISO 80601-2-56, the maximum number of subjects with heating is 32, by applying the standard that should not exceed 30%, and the target is 35, by applying the normal research dropout rate of 10%. * If the research procedure is completed without dropping out of only 32 subjects, the study is terminated.
Detailed description
This study is designed to simultaneously apply both the test and control devices to each subject. All subjects (N = 105) will have the sensors attached at the same anatomical position; therefore, no group assignment (randomization) will be conducted.
- Simultaneous Measurement: Both the Bair Hugger™ Model 370 and XST600 will measure temperature concurrently.
- Target Core Temperature: Only subjects with a core temperature of 36.1 or higher (as measured by Reference Clinical Thermometer) will be included.
Inclusion Criteria
- Males and females aged 19 to 80 years.
- Patients requiring continuous temperature monitoring in the Operating Room or Intensive Care Unit.
- Subjects (or their legal representatives) who have been fully informed about the study and have voluntarily provided written informed consent.
Exclusion Criteria
- Skin Conditions: Presence or high risk of skin diseases, wounds, infections, or allergic reactions (e.g., rash) at the application site (forehead).
- Medication Interference: * Current use of drugs that may interfere with clinical trial results, such as barbiturates (sedatives/hypnotics), thyroid preparations, or antipsychotic drugs (per ISO 80601-2-56).
- Administration of antipyretics within the last 120 minutes or immunization within the last month (per ISO 80601-2-56).
- Medical History: Any underlying medical condition that may significantly impact the interpretation of the clinical results.
- Investigator Discretion: Any individual deemed inappropriate for participation by the principal investigator.
Measurement Methods \& Data Acquisition
- Bair Hugger™ Temperature Monitoring System Model 370
- Setup: Connect the sensor to the cable connector, ensuring the tab is fully inserted and aligned.
- Stabilization: Allow a minimum of 5 minutes for the temperature to stabilize.
- Recording: Once stable, press 'Start' in the app. Data will be recorded for a minimum of 25 minutes post-stabilization.
- Frequency: Measurements will be recorded at 1-minute intervals.
- XST600 Measurement Method
- Recording: Once the measured temperature stabilizes (minimum 5 minutes), press the 'Start' button in the app.
- Duration: The recording duration shall be at least 25 minutes following the stabilization period.
- Automation: Upon clicking 'Start', data is automatically saved at 1-second intervals. The process concludes when the 'End' button is clicked.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal body temperature subjects | – | –This study is designed to simultaneously apply both the test and control devices to each subject. All subjects (N = 105) will have the sensors attached at the same anatomical position; therefore, no group assignment (randomization) will be conducted |
| Subjects with fever | – | –This study is designed to simultaneously apply both the test and control devices to each subject. All subjects (N = 105) will have the sensors attached at the same anatomical position; therefore, no group assignment (randomization) will be conducted |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age and Gender: Men and women aged between 19 and 80 years. Clinical Requirement: Patients who need to monitor their body temperature in the operating room or intensive care unit at Severance Hospital. Voluntary Consent: Subjects (or their legal representatives) who have received a detailed explanation of the study and have voluntarily provided written informed consent. Baseline Temperature: Only subjects with a confirmed core temperature of 36.1 or higher (as measured by a Reference Clinical Thermometer) will be included.
Key inclusion criteria (3 listed)
- Males and females aged 19 to 80 years.
- Patients requiring continuous temperature monitoring in the Operating Room or Intensive Care Unit.
- Subjects (or their legal representatives) who have been fully informed about the study and have voluntarily provided written informed consent.
Key exclusion criteria (5 listed)
- Skin Conditions: Presence or high risk of skin diseases, wounds, infections, or allergic reactions (e.g., rash) at the application site (forehead).
- Medication Interference: * Current use of drugs that may interfere with clinical trial results, such as barbiturates (sedatives/hypnotics), thyroid preparations, or antipsychotic drugs (per ISO 80601-2-56).
- o Administration of antipyretics within the last 120 minutes or immunization within the last month (per ISO 80601-2-56).
- Medical History: Any underlying medical condition that may significantly impact the interpretation of the clinical results.
- Investigator Discretion: Any individual deemed inappropriate for participation by the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body temperature measured with a Bair Hugger Temperature Monitoring System Model 370 thermometer
Time frame: When the measured body temperature of the subject enters the stabilization phase (at least 5 minutes), the body temperature data is recorded, and the test time is at least 25 minutes after the stabilization phase.
Body temperature measured with a Bair Hugger Temperature Monitoring System Model 370 thermomete
1 secondary outcome
Body temperature measured with an XST600 thermometer
Time frame: When the measured body temperature of the subject enters the stabilization phase (at least 5 minutes), the body temperature data is recorded, and the test time is at least 25 minutes after the stabilization phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of All Patients Who Require Monitoring of Their Temperatures Over the Age of 19, run by Yonsei University.
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 3 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyo-Jin Byon, Professor (82-2-2227-4641, jinoben@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature measured with a Bair Hugger Temperature Monitoring System Model 370 thermometer (time frame: When the measured body temperature of the subject enters the stabilization phase (at least 5 minutes), the body temperature data is recorded, and the test time is at least 25 minutes after the stabilization phase.). 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 20 Apr 2026.