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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033644
Receipt No. R000038361
Official scientific title of the study Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Title of the study (Brief title) Clinical application of chest x-ray dynamic photography 1
Region
Japan

Condition
Condition pulmonary embolism
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the diagnostic ability of pulmonary embolism patients with chest x-ray dynamic imaging and contrast CT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Pixel values in the lung field in the intake phase and the expiratory phase frame of 18 lung fields
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Chest x-ray dynamic photography
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) be an adult over 20 years old
(2) To be consented to the document
(3) Patients suspected of pulmonary embolism or patients diagnosed with pulmonary embolism
(4) Chest contrast CT examination was performed
Key exclusion criteria (1) Research subjects who have allergy to the contrast agent
(2) During pregnancy, there is a possibility of pregnancy, within 28 days after childbirth, women corresponding to either breastfeeding
(3) Research subjects who are judged to be difficult to participate in the examination by merging mental disorders or psychiatric symptoms
Target sample size 50

Research contact person
Name of lead principal investigator SHIMADA JIRO
Organization Fukushima Medical University
Division name Futaba Emergency General Medical Support Center
Address 1 Hikariga-oka, Fukushima City, JAPAN
TEL 0245471111
Email jshimada@fmu.ac.jp

Public contact
Name of contact person SHIMADA JIRO
Organization Fukushima Medical University hospital
Division name Emergency and Critical Care Center
Address 1 Hikariga-oka, Fukushima City, JAPAN
TEL 0245471111
Homepage URL
Email jshimada@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Konica Minolta Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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 08 Month 10 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038361

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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