UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060440 |
|---|---|
| Receipt number | R000069147 |
| Scientific Title | Development of a Cardiac Ultrasound Training Phantom and Evaluation of Its Educational Effectiveness |
| Date of disclosure of the study information | 2026/01/25 |
| Last modified on | 2026/01/22 14:46:19 |
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Basic information
Public title
Development of a Cardiac Ultrasound Training Phantom and Evaluation of Its Educational Effectiveness
Acronym
A Study to Evaluate the Usefulness of an Educational Model for Learning Cardiac Ultrasound Examination
Scientific Title
Development of a Cardiac Ultrasound Training Phantom and Evaluation of Its Educational Effectiveness
Scientific Title:Acronym
CUEP Study(Cardiac Ultrasound Education Phantom)
Region
| Japan |
Condition
Condition
Not applicable (Educational study using a cardiac ultrasound training phantom)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of a cardiac ultrasound training phantom developed for educational use in cardiac ultrasound examinations in actual educational settings.
Specifically, ultrasound training using this phantom will be conducted with students and novice learners, and usability will be assessed in terms of operability and ease of use, along with image quality evaluation focusing on the visibility and reproducibility of cardiac structures.
Through these evaluations, this study aims to clarify whether the developed phantom can serve as an effective educational tool for cardiac ultrasound training.
Basic objectives2
Others
Basic objectives -Others
Educational evaluation of usability and image quality of a cardiac ultrasound training phantom
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures of this study are usability evaluation and image quality assessment of cardiac structures during ultrasound training using the cardiac ultrasound training phantom.
Usability will be assessed based on subjective evaluations of operability and ease of use, while image quality will be evaluated based on the visibility and reproducibility of cardiac structures to determine the effectiveness of the phantom as an educational tool.
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound training using a cardiac ultrasound training phantom
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
| 21 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physicians, nurses, and clinical laboratory technologists involved in the clinical practice and education of cardiac ultrasound examinations
Key exclusion criteria
1.Individuals who are unable to fully understand the purpose and procedures of the study and are unable to provide written informed consent.
2.Individuals who are deemed inappropriate for participation in the study by the principal investigator or co-investigators.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | MIKI |
| Middle name | |
| Last name | MATSUKI |
Organization
Bunkyo Gakuin University
Division name
Department of Clinical Laboratory Science, Faculty of Health Science and Technology
Zip code
113-0023
Address
2-4-1 Mukogaoka, Bunkyo-ku, Tokyo, Japan
TEL
08030857718
mmatsuki@bgu.ac.jp
Public contact
Name of contact person
| 1st name | MIKI |
| Middle name | |
| Last name | MASTUKI |
Organization
Bunkyo Gakuin University
Division name
Department of Clinical Laboratory Science, Faculty of Health Science and Technology
Zip code
113-0023
Address
2-4-1 Mukogaoka, Bunkyo-ku, Tokyo, Japan
TEL
08030857718
Homepage URL
mmatsuki@bgu.ac.jp
Sponsor or person
Institute
Bunkyo Gakuin University
Institute
Department
Personal name
MIKI MATSUKI
Funding Source
Organization
Bunkyo Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bunkyo Gakuin University
Address
2-4-1 Mukogaoka, Bunkyo-ku, Tokyo, Japan
Tel
08030857718
mmatsuki@bgu.ac.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 04 | 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
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069147
