UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028072 |
|---|---|
| Receipt number | 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 11:34:31 |
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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
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
eono@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine,Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032140
