UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030198 |
|---|---|
| Receipt number | R000034496 |
| Scientific Title | Dependency on X-ray imaging conditions |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2019/09/13 10:04:59 |
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Basic information
Public title
Dependency on X-ray imaging conditions
Acronym
Dependency on X-ray imaging conditions
Scientific Title
Dependency on X-ray imaging conditions
Scientific Title:Acronym
Dependency on X-ray imaging conditions
Region
| Japan |
Condition
Condition
Bone Fracture, Osteoporosis
Classification by specialty
| Orthopedics | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify evaluation methods that contribute to diagnosis of bone fractures, based on the results of radiography using FUJIFILM X-ray imaging equipment.
Basic objectives2
Others
Basic objectives -Others
To verify influences of X-ray imaging conditions and subject's age.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Approximate evaluation of the amount of characteristic for the X-ray images of each anatomical region and imaging conditions.
Key secondary outcomes
Visual evaluation for the X-ray images of each anatomical region and imaging conditions.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
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
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
x-ray radiography will be performed.
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
| Not applicable |
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 bone fracture
4, Subjects who have been diagnosed with osteoporosis
5, Subjects who are considered inappropriate as research subjects by the PI
Target sample size
123
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Megumi Inoue |
Organization
SOUSEIKAI PS Clinic
Division name
Physician's Dept
Zip code
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka,812-0025
TEL
092-283-7777
megumi-inoue@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Kumashiro |
Organization
SOUSEIKAI Hakata Clinic
Division name
Planning & Coordination Dept.
Zip code
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL
0922837701
Homepage URL
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI PS Clinic
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
FUJIFILM Corporation
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人相生会ピーエスクリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 30 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034496
