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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035095
Receipt No. R000039064
Scientific Title Verification of usefulness of new image processing technology to evaluate the specimen by EUS-FNAB
Date of disclosure of the study information 2018/12/20
Last modified on 2019/07/14

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Basic information
Public title Verification of usefulness of new image processing technology to evaluate the specimen by EUS-FNAB
Acronym Verification of usefulness of new image processing technology to evaluate the specimen by EUS-FNAB
Scientific Title Verification of usefulness of new image processing technology to evaluate the specimen by EUS-FNAB
Scientific Title:Acronym Verification of usefulness of new image processing technology to evaluate the specimen by EUS-FNAB
Region
Japan

Condition
Condition abdominal solid tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of new image processing technology on the correlation between its findings and pathology.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The usefulness of new image processing technology on the correlation between its findings and pathology.
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) pancreatic solid mass suspected malignancy or subepitelial lesions in upper gastrointestinal tract which are required pathological diagnosis
2) providing written informed consent, and
age =or >20
Key exclusion criteria 1) high risk of puncturing cystic part
2) bleeding disorders
3) patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, 252-0374, Japan
TEL +81-42-778-8111
Email kokuwaki@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, 252-0374, Japan
TEL +81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Olympus Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kitasato University Institutional Review Board
Address 1-15-1, Kitasato Minami Sagamihara Kanagawa, Japan
Tel +81-42-778-7756
Email rinri@med.kitasato-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
2018 Year 12 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 12 Month 21 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To clarify the usefulness of new image processing technology on the correlation between its findings and pathology.

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2019 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039064

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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