UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058669 |
|---|---|
| Receipt number | R000066993 |
| Scientific Title | Validation study on the performance of thoracoabdominal separation measurement in a radar-based respiratory rate sensor |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/01 16:36:03 |
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Basic information
Public title
Research on thoracoabdominal separation using rader-based sensors
Acronym
Research on thoracoabdominal separation using rader-based sensors
Scientific Title
Validation study on the performance of thoracoabdominal separation measurement in a radar-based respiratory rate sensor
Scientific Title:Acronym
Validation study on the performance of thoracoabdominal separation measurement in a radar-based respiratory rate sensor
Region
| Japan |
Condition
Condition
paediatric inpatients
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a non-contact radio wave-based thoracic movement sensor, we will measure respiratory movements in the chest and abdomen of healthy children separately and verify the accuracy of the measurements.
Basic objectives2
Others
Basic objectives -Others
A proof-of-concept study on measurement performance
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between changes detected by existing equipment and radio wave sensors
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
| Device,equipment |
Interventions/Control_1
All participants will undergo about 20 minutes of measurement.
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy children
Key exclusion criteria
1) Individuals with implantable medical devices
2) Individuals with thoracic deformities
3) Individuals with skin conditions that make it difficult to attach existing devices
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawaguchi |
Organization
St. Marianna University School of Medicine
Division name
Division of Pediatric Critical Care Medicine, Department of Pediatrics
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
atsushi.kawaguchi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawaguchi |
Organization
St. Marianna University School of Medicine
Division name
Division of Pediatric Critical Care Medicine, Department of Pediatrics
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
Homepage URL
atsushi.kawaguchi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
KONICA MINOLTA, INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel
044-977-8111
N/A
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
聖マリアンナ医科大学(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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 | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066993
