UMIN-CTR Clinical Trial

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