Temperature Change, BodyNCT06677372
Comparative Analysis of Core Body Temperature Measurement
A study testing Body temperature measurement in people with Temperature Change, Body, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison and evaluation of the correlation, accuracy, and precision between a skin-attached temperature sensor and the standard method of deep body temperature measurement, the esophageal thermometer, by measuring and assessing both temperature measurement methods. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Body temperature measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2023to 30 Jun 2025
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 19 years and above, but under 70 years
Who cannot join
- Cases where there were serious side effects during a previous examination performed under sedation or anesthesia
- Currently undergoing treatment for a diagnosed disease
- Diagnosed with esophageal varices or having a history of esophagitis
- Having undergone esophageal and gastric resection surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
JEAYEON PARK, MD, 821036380746, jyeonpark202@gmail.com
About this study
Official title: Comparative Analysis of Core Body Temperature Measurement During Endoscopy: Esophageal Temperature Probe Versus Skin Temperature Sensors
Comparison and evaluation of the correlation, accuracy, and precision between a skin-attached temperature sensor and the standard method of deep body temperature measurement, the esophageal thermometer, by measuring and assessing both temperature measurement methods.
- Conditions
- Temperature Change, Body
- Being tested
- Body temperature measurement
- Keywords
- Esophageal temperature, 3M Spot On, Zero heat flux temperature
- 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.
Body temperature measurementDiagnostic test
Comparative analysis of temperature between esophageal temperature and skin temperature
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Not described Receives: Diagnostic Test: Body temperature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Esophageal Temperature Probe versus Skin Temperature Sensors
Measured: From enrollment to the end of the treatment at 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Dec 2023
- Primary completion29 Feb 2024
- Study completion30 Jun 2025 (estimated)
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.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jong Yu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677372
- Sponsor's protocol ID
- 2311-164-1488
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Core Body Temperature Measurement During Endoscopy: Esophageal Temperature Probe Versus Skin Temperature Sensors
- ClinicalTrials.gov ID
- NCT06677372
- Acronym / sponsor ID
- 2311-164-1488
- Conditions
- Temperature Change, Body
- Keywords
- Esophageal temperature, 3M Spot On, Zero heat flux temperature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
Comparison and evaluation of the correlation, accuracy, and precision between a skin-attached temperature sensor and the standard method of deep body temperature measurement, the esophageal thermometer, by measuring and assessing both temperature measurement methods.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Diagnostic Test: Body temperature measurement |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged 19 years and above, but under 70 years
Key exclusion criteria (4 listed)
- Cases where there were serious side effects during a previous examination performed under sedation or anesthesia
- Currently undergoing treatment for a diagnosed disease
- Diagnosed with esophageal varices or having a history of esophagitis
- Having undergone esophageal and gastric resection surgery
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 |
|---|---|---|
| Body temperature measurementComparative analysis of temperature between esophageal temperature and skin temperature | Diagnostic test | Healthy subjects |
Primary outcome
Body temperature
Time frame: From enrollment to the end of the treatment at 1month
Esophageal Temperature Probe versus Skin Temperature Sensors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body temperature measurement in people with Temperature Change, Body, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Nov 2024. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: From enrollment to the end of the treatment at 1month). 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 6 Nov 2024.