UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054289 |
|---|---|
| Receipt number | R000062006 |
| Scientific Title | Semi-automated robotic neck ultrasound imaging |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/05/02 09:01:56 |
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Basic information
Public title
Semi-automated robotic neck ultrasound imaging
Acronym
Robotic neck ultrasound imaging
Scientific Title
Semi-automated robotic neck ultrasound imaging
Scientific Title:Acronym
Robotic neck ultrasound imaging
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ultrasound imaging is used as a first-line screening method for neck diseases, but the number of examiners is inadequate. Therefore, we have developed a robotic system that can perform ultrasound examinations in place of an examiner. We will clarify whether the developed robot can reduce the examiner's time while assuring the same quality as a manual examination by a skilled examiner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inspectors' time restraints
Key secondary outcomes
Ultrasound image quality
Subject pressure sensation
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 |
Interventions/Control_1
Robotics and manual ultrasound image acquisition of the entire neck
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Staff not involved in the affiliation or position of the principal investigator.
Persons who can obtain written consent from the individual to participate in the research of their own free will.
Key exclusion criteria
Persons who have trauma to the neck
Persons who are currently visiting the hospital due to a head and neck disease, etc.
Persons belonging to the research group to which the principal investigator belong
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Tsumura |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Health and Medical Research Institute
Zip code
305-8564
Address
1-2-1, Namiki, Tsukuba, Ibaraki
TEL
05035226388
ryosuke.tsumura@aist.go.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Tsumura |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Health and Medical Research Institute
Zip code
305-8564
Address
1-2-1, Namiki, Tsukuba, Ibaraki
TEL
05035226388
Homepage URL
ryosuke.tsumura@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology
Address
1-1-1 Higashi, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.go.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 | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062006
