UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003183 |
|---|---|
| Receipt number | R000003854 |
| Scientific Title | Assessment of the liver and varices using contrast enhanced three-dimensional ultrasonography. |
| Date of disclosure of the study information | 2010/02/15 |
| Last modified on | 2010/02/15 13:53:19 |
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Basic information
Public title
Assessment of the liver and varices using contrast enhanced three-dimensional ultrasonography.
Acronym
Contrast enhanced three-dimensional ultrasonography of the liver and varices.
Scientific Title
Assessment of the liver and varices using contrast enhanced three-dimensional ultrasonography.
Scientific Title:Acronym
Contrast enhanced three-dimensional ultrasonography of the liver and varices.
Region
| Japan |
Condition
Condition
Liver disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the blood flow of the liver and varices using contrast enhanced three-dimensional ultrasonography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Diagnostic ability of the blood flow of the liver.
2. Diagnostic ability of esophagogastric varices.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Contrast enhanced three-dimensional ultrasonography using sonazoid
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Liver disease
2. Written informed consent
Key exclusion criteria
Allergy for egg
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Imamura |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Division of Hepatology, Department of Internal Medicine
Zip code
Address
18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
03-3823-2101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Imamura |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Division of Hepatology, Department of Internal Medicine
Zip code
Address
18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
03-3823-2101
Homepage URL
jun.imamu@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 15 | 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
| 2010 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
| 2010 | Year | 02 | Month | 15 | Day |
Last modified on
| 2010 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003854
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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