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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008488
Receipt No. R000009975
Scientific Title a study relating to the utility of contrast enhanced EUS with sonazoid for diagnose of hepato-pancreato-biliary disease.
Date of disclosure of the study information 2012/07/20
Last modified on 2015/07/21

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Basic information
Public title a study relating to the utility of contrast enhanced EUS with sonazoid for diagnose of hepato-pancreato-biliary disease.
Acronym a study relating to the utility of contrast enhanced EUS with sonazoid for diagnose of hepato-pancreato-biliary disease
Scientific Title a study relating to the utility of contrast enhanced EUS with sonazoid for diagnose of hepato-pancreato-biliary disease.
Scientific Title:Acronym a study relating to the utility of contrast enhanced EUS with sonazoid for diagnose of hepato-pancreato-biliary disease
Region
Japan

Condition
Condition All indication cases for ceEUS
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to assess the efficacy of sonazoid ce-EUS in the diagnose of hepato-pancreato-biliary disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic capability
Key secondary outcomes Lesion detectability, amounts of medicine

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 sonazoid 0.01ml/Kg
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 All indication cases for ce-EUS
Key exclusion criteria Patients without written informed consent

Patients with severely impaired organ
function

Patients considered ineligible for this study

Patients with allergy for sonazoid

Patients with allergy for egg

Patients with possibility of pregnant
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ashida Reiko
Organization Osaka Prefectural Hospital Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Departments of Cancer Survey and Gastrointestinal Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL 06-6972-1181
Email asida-re@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ashida Reiko
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Departments of Cancer Survey and Gastrointestinal Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL 06-6972-1181
Homepage URL
Email asida-re@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Departments of Cancer Survey and Gastrointestinal Oncology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 大阪府立成人病センター

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 20 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
2012 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 02 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 11 Month 30 Day
Date analysis concluded
2015 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 20 Day
Last modified on
2015 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009975

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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