UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028551 |
|---|---|
| Receipt number | R000032678 |
| Scientific Title | Study about usefullness of new ultrasound machine in diagnosis and therapy for liver disease |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2018/06/19 18:56:19 |
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Basic information
Public title
Study about usefullness of new ultrasound machine in diagnosis and therapy for liver disease
Acronym
Usefullness of new ultrasound machine
Scientific Title
Study about usefullness of new ultrasound machine in diagnosis and therapy for liver disease
Scientific Title:Acronym
Usefullness of new ultrasound machine
Region
| Japan |
Condition
Condition
liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the image and the function of the ultrasound machine which Japaneses doctors and technicians want and to contribute the ability of diagnosis and therapy for liver disease using new ultrasound machine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of the image and the function of the ultrasound machine
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
In persons who recieve this study,the examination time will be prolonged for about 15 minutes.
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. Age 20 y.o or over
2. persons who will have the exam of ultrasound
3. persons who are not pregnant
4. The person that a written consent was provided after having received enough explanation
Key exclusion criteria
1. Age less than 20 y.o.
2. persons who are pregnant
3. persons who are judged as an inappropriate subject by the principal investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichiro Shiina |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
sshiina@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Imai |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
y-imai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032678
