UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048005 |
|---|---|
| Receipt number | R000054722 |
| Scientific Title | Development of diagnostic and therapeutic support tools for scoliosis using deep learning |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2022/06/09 11:29:07 |
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Basic information
Public title
Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Acronym
Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Scientific Title
Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Scientific Title:Acronym
Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Region
| Japan | Asia(except Japan) | North America |
| Australia | Europe |
Condition
Condition
Scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Image items related to the progression of scoliosis are evaluated using AI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
For X-ray images of patients with scoliosis, we will compare and examine which is more accurate, the progress prediction by AI or the progress prediction by a spine surgeon. We plan to use images from six months, one year, and two years to study the progress.
Key secondary outcomes
Images other than X-rays are also used as secondary outcomes. Patient groups are stratified and evaluated by degree of bone maturity.
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
X-ray of 6, 12, and 24 months in patients with scoliosis was evaluated.
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
| 10 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
idiopathic scoliosis
Key exclusion criteria
Exclude scoliosis from other disorders such as non-idiopathic, neurological, symptomatic, and congenital.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Seki |
Organization
University of Toyama
Division name
Orthopaedic surgery
Zip code
930-0194
Address
Sugitani 2630
TEL
0764347353
seki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Seki |
Organization
University of Toyama
Division name
Orthopaedic surgery
Zip code
930-0194
Address
Sugitani 2630
TEL
0764347353
Homepage URL
seki@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Kakenhi
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
University of Toyama
Address
Sugitani2630
Tel
0764347353
seki@med.u-toyama.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 10 | 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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054722
