UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052710 |
|---|---|
| Receipt number | R000060102 |
| Scientific Title | Data collection for the development and improvement of applications that measure vital signs from photo/video data taken with smartphones. |
| Date of disclosure of the study information | 2024/11/07 |
| Last modified on | 2024/03/21 17:17:53 |
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Basic information
Public title
Data collection for the development and improvement of applications that measure vital signs from photo/video data taken with smartphones.
Acronym
Data collection for the development and improvement of applications that measure vital signs from photo/video data taken with smartphones.
Scientific Title
Data collection for the development and improvement of applications that measure vital signs from photo/video data taken with smartphones.
Scientific Title:Acronym
Data collection for the development and improvement of applications that measure vital signs from photo/video data taken with smartphones.
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily validate the analysis system designed for Caucasians using healthy Japanese individuals, with the aim of obtaining valuable information for the future development and validation trials of the application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate
Respiratory function tests (SpO2, vital capacity (VC), forced vital capacity (FVC))
Acquisition of photo/video data
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese males and females aged 20 to 64 years old when informed consent.
2. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects using beta-blockers, steroids, or beta2 agonists (bronchoconstrictors and bronchodilators).
2. Subjects with the following medical history or comorbidities:
History of thoracic or abdominal surgery
Myocardial infarction or angina pectoris
Uncontrolled hypertension (Grade III or higher)
3. Subjects who cannot remove nail polish or artificial nails on the day of the examination.
4. Subjects planning to participate in another clinical trial between the date of consent and the examination visit.
5. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Micron Inc.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 07 | 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
| 2023 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratively evaluate the correlation between measurements obtained from respiratory function tests and Smartphone.
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060102
