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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030198
Receipt No. 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

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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
Email 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
Email hiroko-kumashiro@lta-med.com

Sponsor
Institute SOUSEIKAI PS Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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