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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039033
Receipt No. R000044510
Scientific Title Observation of azygos vein valve by endobronchial ultrasonography
Date of disclosure of the study information 2020/01/06
Last modified on 2019/12/30

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Basic information
Public title Observation of azygos vein valve by endobronchial ultrasonography
Acronym Observation of azygos vein by EBUS
Scientific Title Observation of azygos vein valve by endobronchial ultrasonography
Scientific Title:Acronym Observation of azygos vein by EBUS
Region
Japan

Condition
Condition Patients receiving EBUS
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether azygos vein valve can be observed with EBUS
Basic objectives2 Others
Basic objectives -Others Anatomic feature
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether azygos vein valve can be observed with EBUS
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Receiving EBUS
2) Aged 20 or more
3) Written informed consent
Key exclusion criteria 1) Nothing particular
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Nakashima
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code 693-8501
Address 89-1 Enya-cho, Izumo, Shimane, Japan
TEL 0853-20-2580
Email kazuhin@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Kazuhisa
Middle name
Last name Nakashima
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code 693-8501
Address 89-1 Enya-cho, Izumo, Shimane, Japan
TEL 0853-20-2580
Homepage URL
Email kazuhin@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization None
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 The institutional review board of Shimane University Faculty of Medicine
Address 89-1 Enya-cho, Izumo, Shimane, Japan
Tel 0853-20-2515
Email kenkyu@med.shimane-u.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
2020 Year 01 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
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
2019 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 14 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular.

Management information
Registered date
2019 Year 12 Month 30 Day
Last modified on
2019 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044510

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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