UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019178 |
|---|---|
| Receipt number | R000022150 |
| Scientific Title | Evaluation of C-arm angiographic imaging system for abdominal intervention |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/09/30 09:23:49 |
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Basic information
Public title
Evaluation of C-arm angiographic imaging system for abdominal intervention
Acronym
Evaluation of C-arm angiographic imaging system for abdominal intervention
Scientific Title
Evaluation of C-arm angiographic imaging system for abdominal intervention
Scientific Title:Acronym
Evaluation of C-arm angiographic imaging system for abdominal intervention
Region
| Japan |
Condition
Condition
abdominal tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the clinical usefulness of multi-phase C-arm CT imaging and Parenchymal Blood Volume (PBV) imaging for abdominal intervention by using C-arm angiographic imaging system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: tumor number, tumor morphology, tumor contrast effect, vascular occlusion range, hepatic blood flow, hepatic volume
Evaluation period: dynamic contrast enhanced CT within 3months before and after intervention, multi-phase C-arm CT imaging and PBV imaging during intervention
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
| Device,equipment | Other |
Interventions/Control_1
Multi-phase C-arm CT imaging and PBV imaging will be taken one or more times (as necessary) during angiography
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
Patients who meet all the following criteria can be included in the study:
1. Patients have indication for abdominal angiography or intervention.
2. Written informed consent is obtained.
3. Adult (20 years old or older)
Key exclusion criteria
Patients who meet any of the following criteria are not eligible for the study:
1. Patients have contraindication to contrast media.
2. Patients are currently or intending to become pregnant or are lactating.
3. Inadequate physical condition judged by the physician.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Hamuro |
Organization
Osaka City University Graduate School of Medicine
Division name
Diagnostic and Interventional Radiology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3831
hamuro@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Hamuro |
Organization
Osaka City University Graduate School of Medicine
Division name
Diagnostic and Interventional Radiology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3831
Homepage URL
hamuro@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine Diagnostic and Interventional Radiology
Institute
Department
Personal name
Funding Source
Organization
Siemens Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2015 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022150
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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