UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061460 |
|---|---|
| Receipt number | R000070330 |
| Scientific Title | Evaluation of the Usefulness of Abierto Reading Support Solution Temporal Subtraction For Bone for Detecting Fracture Findings in Emergency Department Patients |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/06 21:31:30 |
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Basic information
Public title
Study of AI-Assisted Imaging Analysis Aimed at Preventing Missed Fractures in the Emergency Department
Acronym
SAFE Fracture Study
(Supportive AI for Fracture Evaluation Study)
Scientific Title
Evaluation of the Usefulness of
Abierto Reading Support Solution Temporal Subtraction For Bone
for Detecting Fracture Findings in Emergency Department Patients
Scientific Title:Acronym
DETECT-B Study
(Detection Enhancement using Temporal-subtraction for Cortical Trauma of Bone)
Region
| Japan |
Condition
Condition
Among patients who visited the emergency department and underwent trunk CT examination, cases in which a prior trunk CT had previously been performed at our hospital and the past images were stored in the PACS.
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively evaluate the effectiveness of TSB in supporting the detection of fracture findings in patients who visited the emergency department and underwent trunk CT examination, among those who had previously undergone trunk CT imaging at our hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the impact of TSB use on the sensitivity and specificity for detecting fracture findings (including traumatic and pathological fractures), using specialist diagnosis as the gold standard.
Key secondary outcomes
Evaluation of the agreement between fracture diagnoses made by the study investigators and specialist diagnoses
Evaluation of the fracture detection rate in the initial assessment by emergency department physicians and its agreement with specialist diagnoses
Assessment of the impact of TSB on reader`s diagnostic confidence scores
Comparison of the usefulness of TSB according to fracture site
Evaluation of the presence or absence of bone metastases
Additional usefulness of TSBV for detecting spinal canal changes associated with fractures
Additional usefulness of TSB in differentiating traumatic fractures from pathological fractures
Exploratory evaluation of the correlation between the quantitative range of color tone changes on TSB subtraction images and fracture findings
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the emergency department of our hospital and underwent trunk CT imaging
Cases in which prior trunk CT images obtained at our hospital were stored in the PACS and available for subtraction analysis
Age over 18 years
Slice thickness under 5.0 mm
Field of view 200-800 mm
tube voltage 70-140 kVp
Key exclusion criteria
Cases in which bone evaluation is markedly difficult due to metal implants or imaging artifacts
Cases in which subtraction analysis is inappropriate because the imaging range or acquisition conditions differ substantially from those of prior images
Cases in which the patient or their legal representative has expressed refusal to participate in the study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Yasuda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
330-0834
Address
847 Amanuma-cho 1-chome, Omiya-ku, Saitama-shi, Saitama, Japan
TEL
048-647-2111
yasudahideto@me.com
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Yasuda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
330-0834
Address
847 Amanuma-cho 1-chome, Omiya-ku, Saitama-shi, Saitama, Japan
TEL
048-647-2111
Homepage URL
yasudahideto@me.com
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University Saitama Medical Center
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
Jichi Medical University Saitama Medical Center
Address
847 Amanuma-cho 1-chome, Omiya-ku, Saitama-shi, Saitama, Japan
Tel
048-647-2111
yasudahideto@me.com
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
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 05 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070330
