UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008488 |
|---|---|
| Receipt number | 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 08:53:54 |
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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
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
asida-re@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Departments of Cancer Survey and Gastrointestinal Oncology
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
None
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
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
Value
https://center6.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 |
