UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050109 |
|---|---|
| Receipt number | R000057082 |
| Scientific Title | Data collection for the development of IoT devices for toilet training for young children |
| Date of disclosure of the study information | 2023/01/28 |
| Last modified on | 2023/02/20 11:18:28 |
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Basic information
Public title
Data collection for the development of IoT devices for toilet training for young children
Acronym
Data collection for the development of IoT devices for toilet training for young children
Scientific Title
Data collection for the development of IoT devices for toilet training for young children
Scientific Title:Acronym
Data collection for the development of IoT devices for toilet training for young children
Region
| Japan |
Condition
Condition
None (for healthy subjects)
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Collection of infant bladder echo imaging data, as well as measurement data for functional verification of the prototype
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infant bladder echo imaging data and measurement data from the prototype machine
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
-Using an echo device (non-medical device) and a prototype machine, ultrasound measurements of the bladder were performed under MI values that meet FDA 510(k).
-The duration is one day (approximately 4 hours), with ultrasound measurements of approximately 2 minutes every hour.
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
| 2 | years-old | <= |
Age-upper limit
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Young children aged 2-4 years at the time of obtaining consent
Key exclusion criteria
-Have travelled abroad within the past three months.
-Those with mental or neurological disorders, including claustrophobia, localised phobia, developmental disabilities, etc.
-Those with skin diseases.
-Those who have had allergic reactions to ointments in the past.
-Those with a pacemaker.
-Other cases in which the principal investigator or other relevant personnel deem it inappropriate to participate in this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kozai |
Organization
KYOCERA Corporation
Division name
IoT Business Development Division, Corporate Management Promotion Group
Zip code
220-0012
Address
3-7-1 Minatomirai, Nishi-ku, Yokohama, Kanagawa
TEL
045-605-7100
IoT.business_sh@kyocera.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kozai |
Organization
KYOCERA Corporation
Division name
IoT Business Development Division, Corporate Management Promotion Group
Zip code
220-0012
Address
3-7-1 Minatomirai, Nishi-ku, Yokohama, Kanagawa
TEL
045-605-7100
Homepage URL
IoT.business_sh@kyocera.jp
Sponsor or person
Institute
KYOCERA Corporation
Institute
Department
Personal name
Funding Source
Organization
KYOCERA 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
Japan Conference of Clinical Research
Address
1-13-23 Minami Ikebukuro, Toshima-ku, Tokyo
Tel
03-6868-7022
jccr-info@jccr.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 28 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057082
