UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034722
Receipt No. 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 (Ver. 4)

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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
Email 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
Email hiroko-kumashiro@lta-med.com

Sponsor
Institute SOUSEIKAI Fukuoka Mirai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039588