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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021524
Receipt No. 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

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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
Email 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
Email miyakawat@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine. Department of Radiology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024822

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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