UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057841 |
|---|---|
| Receipt number | R000066122 |
| Scientific Title | Finger Temperature VALidation Study Using a Wearable Ring Device (FiT-VAL Study) |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/12 20:56:49 |
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Basic information
Public title
Validation Study of Finger Temperature Measurement Using a Finger Temperature Monitoring Device
Acronym
A study to evaluate the accuracy of a device that measures finger temperature
Scientific Title
Finger Temperature VALidation Study Using a Wearable Ring Device (FiT-VAL Study)
Scientific Title:Acronym
FiT-VAL Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to validate the accuracy of finger temperature measurements using a wearable finger temperature device in humans. In addition, the study also evaluates the validity of temperature measurements under varying ambient temperature conditions.
Basic objectives2
Others
Basic objectives -Others
Validation of Temperature Measurement Accuracy of a Finger Temperature Monitoring Device
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation, agreement, and temporal trends between finger temperature measured by thermography and that measured by the finger temperature monitoring device
Key secondary outcomes
1. Correlation, agreement, and temporal trends between finger temperature measured by thermography and that measured by the finger temperature monitoring device, analyzed by individual, sex, and ambient room temperature.
2. Safety and tolerability (based on questionnaire responses).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will wear a finger temperature measurement device and alternate every 40 minutes between rooms maintained at 25 and 15 degrees Celsius. Finger temperature will be measured throughout. A total of 120 minutes will be spent in the 25 degrees Celsius room, and 80 minutes in the 15 degrees Celsius room.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese males and females aged between 20 and 50 years at the time of obtaining informed consent
(2) Individuals with a BMI between 18.5 and 30
(3) Individuals who have sufficient decision-making capacity, received a full explanation of the study objectives and procedures, fully understood the contents, voluntarily agreed to participate, and provided written informed consent
Key exclusion criteria
1. Individuals currently undergoing pharmacological treatment for any disease
2. Individuals with a history of, or currently being treated for, serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disorders, adrenal disorders, or other metabolic diseases
3. Individuals with a history of, or currently diagnosed with, autoimmune diseases such as collagen disease or rheumatoid arthritis
4. Individuals with chronic diseases who are regularly taking medications
5. Individuals with known allergies to metals or resins
6. Individuals with implanted metallic medical devices such as pacemakers
7. Individuals with visible inflammation, trauma, or dermatological conditions (e.g., erythema, erosion, contact dermatitis) on the skin of the left hand (dorsum and palm)
8. Individuals with visible deformity, edema, or limited range of motion in the left ring finger
9. Individuals who have donated more than 200 mL of blood in the past month or more than 400 mL within the past three months
10. Individuals who are aware of having anemia in daily life
11. Individuals who are aware of cold sensitivity (poor peripheral circulation) in the hands or feet
12. Individuals with a history or current condition of drug or alcohol dependence
13. Individuals who experience any symptoms (e.g., headaches, rhinitis, urticaria) in response to temperature changes such as cold-induced urticaria or temperature-sensitive allergies
14. Pregnant or lactating women, or those who may be pregnant
15. Individuals who are unable to remove rings or other accessories from their hands on the day of the study
16. Individuals currently participating in another clinical trial, or who have participated in another clinical trial within the past 3 months
17. Any other individuals deemed unsuitable for participation in the study by the principal investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Nishioka |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
m.nishioka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Kajiyama |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
Homepage URL
s.kajiyama@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-4405-1899
ethics_board@drc-web.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
ユニチカガーメンテック株式会社
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066122
