UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034722 |
|---|---|
| Receipt number | R000039588 |
| Scientific Title | Evaluation of luminance analysis of the DIP method using X-ray imaging of bones of hands. |
| Date of disclosure of the study information | 2018/11/06 |
| Last modified on | 2020/05/02 16:12:00 |
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Basic information
Public title
Evaluation of luminance analysis of the DIP method using X-ray imaging of bones of hands.
Acronym
Evaluation of luminance analysis of the DIP method using X-ray imaging of bones of hands.
Scientific Title
Evaluation of luminance analysis of the DIP method using X-ray imaging of bones of hands.
Scientific Title:Acronym
Evaluation of luminance analysis of the DIP method using X-ray imaging of bones of hands.
Region
| Japan |
Condition
Condition
Bone fracture, osteoporosis
Classification by specialty
| Orthopedics | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To take X-rays using both new and already certified DR devices to compare.
Basic objectives2
Others
Basic objectives -Others
Clarify the difference caused by age and gender.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate correlation of X-ray imaging captured by both new and already certified DR devices.
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
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Frontal plain radiographs of the bones of hands
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who will give written consents for participating in this clinical research
2. Male/Female subjects aged 20 and over
Key exclusion criteria
1. Subjects who are either pregnant or breast-feeding.
2. Subjects who are clearly suffering from serious acute disease.
3. Subjects who have history of previous or current fracture of hand.
4. Subjects who have been diagnosed with osteoporosis.
5. Subjects who are considered inappropriate as research subjects by PIs
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Matsuki |
Organization
SOUSEIKAI Fukuoka Mirai Hospital
Division name
Clinical Research Center
Zip code
813-0017
Address
3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL
092-662-3608
shunji-matsuki@lta-med.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kumashiro |
Organization
SOUSEIKAI Hakata Clinic
Division name
Planning & Coordination Dept.
Zip code
812-0025
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL
0922837701
Homepage URL
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Fukuoka Mirai Hospital
Institute
Department
Personal name
Funding Source
Organization
Canon Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Canon Inc.
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.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
医療法人相生会 福岡みらい病院（福岡県）
キヤノン株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 06 | 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
We evaluated the X-ray imaging of bones of hands captured by both new and already certified DR devices, and found high correlation between them.
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2020 | 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=R000039588
