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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028072
Receipt No. R000032140
Scientific Title Evaluation of clinical use of EUS-elastography using Shear Wave Measurement (SWM) for gastroenterological disorders.
Date of disclosure of the study information 2017/10/01
Last modified on 2019/03/01

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Basic information
Public title Evaluation of clinical use of EUS-elastography using Shear Wave Measurement (SWM) for gastroenterological disorders.
Acronym N-EUS-SWE study
Scientific Title Evaluation of clinical use of EUS-elastography using Shear Wave Measurement (SWM) for gastroenterological disorders.
Scientific Title:Acronym N-EUS-SWE study
Region
Japan

Condition
Condition Abdominal organs
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the tissue elasticity of abdominal organs by EUS-shear wave elastography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The tissue elasticity value of each organs, each diseases
Key secondary outcomes Incidence of complication of EUS-SWE
Correlation tissue elasticity with organ function
Change of tissue elasticity by intervention
Diagnostic performance of EUS-SWE of each diseases

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 Observation by Endoscopic ultrasonography
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)Patients who need to undergo EUS observation or EUS intervention for abdominal diseases.
2)Patients who provided written informed consent
Key exclusion criteria Patients who are not indicated for endoscopy.
1)Patients with poor general condition
2)Patients with gastrointestinal perforation
3)Patients with strangulated ileus
4)Patients with severe comorbidities
5)Patients with mental disorder
6)Patients judged as inappropriate by attendant doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eizaburo Ohno
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2602
Homepage URL
Email eono@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine,Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hitachi, Ltd. Healthcare Ultrasound R&D Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 01 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 04 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032140

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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