UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057109 |
|---|---|
| Receipt number | R000065258 |
| Scientific Title | Study device evaluation study |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2025/03/14 15:29:54 |
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Basic information
Public title
Study device evaluation study
Acronym
Study device evaluation study
Scientific Title
Study device evaluation study
Scientific Title:Acronym
Study device evaluation study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the accuracy of the currently developing Device (study device) by comparing the data obtained from it with that obtained from Ultrasound Echo
Basic objectives2
Others
Basic objectives -Others
Correlation between volumes measured using the study device and those obtained via ultrasound echography.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of data obtained from the currently developing Device (study device) and Ultrasound Echo
Key secondary outcomes
-
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 | Other |
Interventions/Control_1
Measurement A: Wear Measurement Device under developing for up to 3 hours
Measurement B:Wear Measurement Device under developing for up to 2 hours x 3 times x 2 days
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese men and women between the ages of 20 and 60 at the time of consent.
2)Participants who have been fully informed of the purpose and content of the study, and submit the written informed consent form.
3)Participants who can report their own urge to urinate.
4)Participants who can comply with the restrictions from the day before the study.
Key exclusion criteria
1)Participants who currently suffer from or have a history of serious heart disease, pulmonary disease, digestive system disease (esophagus, stomach, small intestine, large intestine, liver, pancreas, etc.), high blood pressure, diabetes, malignant tumors, etc.
2)Participants who are currently undergoing treatment for the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases.
3)Participants with a medical history related to urination who are currently receiving treatment.
4)Participants who are aware of frequent urination.
5)Participants who cannot drink 500 mL of water within 15 minutes.
6)Participants who regularly use medications, quasi-drugs, or health foods (such as foods for specified health uses, foods with nutrient function claims, foods with functional claims, supplements, etc.) that may affect the various tests conducted within this study.
7)Participants who are currently receiving treatment at a medical institution for diseases that may affect the various tests conducted within this study.
8)Participants who have or may have metallic foreign objects in or on the surface of their abdomen.
9)Participants who are participating in a clinical study or have participated in another clinical study within 1 month from the date of obtaining consent.
10)Participants who plan to participate in another clinical study during the study period.
11)Participants who may develop skin irritation from contact with medical tape or similar materials.
12)Participants who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kouta |
| Middle name | |
| Last name | Kobayashi |
Organization
TANITA Corporation
Division name
Research and Development
Zip code
174-8630
Address
1-14-2 Maeno-cho, Itabashi-ku, Tokyo
TEL
03-3968-2111
kotaku@tanita.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
TANITA Corporation
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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 21 | 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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 02 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065258
