UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022611 |
|---|---|
| Receipt number | R000026063 |
| Scientific Title | Transcatheter Catheterl Embolization with N-butyl-2-cyanoacrylate |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/11/05 15:45:34 |
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Basic information
Public title
Transcatheter Catheterl Embolization with N-butyl-2-cyanoacrylate
Acronym
NBCA of embolic meterial
Scientific Title
Transcatheter Catheterl Embolization with N-butyl-2-cyanoacrylate
Scientific Title:Acronym
NBCA of embolic meterial
Region
| Japan |
Condition
Condition
The patient with the situation that transcatheter embolization has to be performed using NBCA
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
NBCA (n-butyl-2-cianoacrylate) is used widely internationally NBCA has the excellent feature that approved embolic materials don't have in the transarterial embolization. But it isn't insurance coverage except for treatment of gastric varices under endoscopy in Japan. This purpose is to confirm the safety and the validity of NBCA as embolic material in transcatheter embolization in emergency case that NBCA is more profitable than other embolic material.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consideration for embolic effect using CT after about 1 week
Key secondary outcomes
Check whether there is any allergy or toxication
Check whether there is complication of characteristic NBCA
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Target vessel is embolized using NBCA in transcatheter embolization.
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
The case in which The usage of NBCA is more effective than other embolic materials in transcatheter embolization.
Target disease: Bleeding and vascular disease, for example, aneurysm.
Key exclusion criteria
The case in which the usage of other embolic materials is more effective than NBCA in transcatheter embolization.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Furuta |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3760
Homepage URL
akihirof@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Sceience and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 08 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 30 | 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
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026063
