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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023875
Receipt No. R000027503
Scientific Title A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease
Date of disclosure of the study information 2018/03/31
Last modified on 2019/09/09

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Basic information
Public title A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease
Acronym A development of less invasive dynamic imaging inspection
Scientific Title A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease
Scientific Title:Acronym A development of less invasive dynamic imaging inspection
Region
Japan

Condition
Condition respiratory disorder, pulmonary arteriopathy and aortic disease
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 development of less invasive dynamic imaging inspection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes a diameter of pulmonary artery and Aorta, length of rib cage
Key secondary outcomes clinical usefulness

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 X-ray apparatus
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
100 years-old >=
Gender Male and Female
Key inclusion criteria The Patient could get the erect position,
Key exclusion criteria pregnant woman
Target sample size 100

Research contact person
Name of lead principal investigator
1st name AKINAGA
Middle name
Last name SONODA
Organization Shiga University of Medical Science
Division name Radiology,
Zip code 5202192
Address seta tsukinowacho, Otsu, Shiga
TEL 810775482288
Email akinaga@bells.shiga-med.ac.jp

Public contact
Name of contact person
1st name AKINAGA
Middle name
Last name SONODA
Organization Shiga Uniceristy of Medical Science
Division name Radiology
Zip code 5292192
Address seta tsukinowacho, Otsu, Shiga
TEL 810775482288
Homepage URL
Email akinaga@belle.shiga-med.ac.jp

Sponsor
Institute Shiga Uniceristy of Medical Science
Institute
Department

Funding Source
Organization Shiga university of medical science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiga University of Medical Science
Address Setastukinowacho, Otsu, Shiga
Tel +81775483576
Email hqrec@belle.shiga-med.ac.jp

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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027503

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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