UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021524 |
|---|---|
| Receipt number | R000024822 |
| Scientific Title | Evaluation of contrast-enhanced ultrasonography in blunt abdominal injury. |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2018/03/19 09:49:53 |
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Basic information
Public title
Evaluation of contrast-enhanced ultrasonography in blunt abdominal injury.
Acronym
Evaluation of contrast-enhanced ultrasonography in blunt abdominal injury.
Scientific Title
Evaluation of contrast-enhanced ultrasonography in blunt abdominal injury.
Scientific Title:Acronym
Evaluation of contrast-enhanced ultrasonography in blunt abdominal injury.
Region
| Japan |
Condition
Condition
Hepatic injury, splenic injury, renal injury
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Radiology |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate CEUS can be a substitute for CECT in the follow-up study of blunt abdominal injury.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Description of injury
Presence or absence of vascular injury
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
| Medicine | Device,equipment |
Interventions/Control_1
We perform CEUS during much of the same period in the follow-up CECT of hepatic, splenic, or renal injury.
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
Patient who diagnosed hepatic, splenic, or renal injury.
Key exclusion criteria
a person falling under any of the following;
1) No concent
2) allergic to eggs or egg products
3) pregnancy
4) assessd that ultrasonography is difficult
5) assessd to be inappropriate in other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyakawa Takashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Radiology
Zip code
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki, Kanagawa, 216-8511, Japan.
TEL
044-977-8111
miyakawat@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyakawa Takashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Radiology
Zip code
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki, Kanagawa, 216-8511, Japan.
TEL
044-977-8111
Homepage URL
miyakawat@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine. Department of Radiology
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | 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
We could not obtain consent of the exam.
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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2018 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024822
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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