NCT06677372

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 6, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

November 2, 2024

Last Update Submit

November 5, 2024

Conditions

Temperature Change, Body

Keywords

Esophageal temperature3M Spot OnZero heat flux temperature

Outcome Measures

Primary Outcomes (1)

  • Body temperature

    Esophageal Temperature Probe versus Skin Temperature Sensors

    From enrollment to the end of the treatment at 1month

Study Arms (1)

Healthy subjects

EXPERIMENTAL
Diagnostic Test: Body temperature measurement

Interventions

Body temperature measurementDIAGNOSTIC_TEST

Comparative analysis of temperature between esophageal temperature and skin temperature

Healthy subjects

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged 19 years and above, but under 70 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Body Temperature Changes

Interventions

Body Temperature

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2024

First Posted

November 6, 2024

Study Start

December 1, 2023

Primary Completion

February 29, 2024

Study Completion

June 30, 2025

Last Updated

November 6, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)