UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022041 |
|---|---|
| Receipt number | R000025407 |
| Scientific Title | The Utility of Advanced Angiographic Imaging Applications in Neuro-endovascular Procedures (Dynamic 4D Imaging) |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2021/05/05 12:25:20 |
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Basic information
Public title
The Utility of Advanced Angiographic Imaging Applications in Neuro-endovascular Procedures (Dynamic 4D Imaging)
Acronym
The Utility of Advanced Angiographic Imaging Applications in Neuro-endovascular Procedures (Dynamic 4D Imaging)
Scientific Title
The Utility of Advanced Angiographic Imaging Applications in Neuro-endovascular Procedures (Dynamic 4D Imaging)
Scientific Title:Acronym
The Utility of Advanced Angiographic Imaging Applications in Neuro-endovascular Procedures (Dynamic 4D Imaging)
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Neurosurgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce a burden on patient by inflection of Dyna 4Dimaging and inspect what can improve quality of diagnosis and treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
efficacy and safety of dynamic 4D imaging during endovascular treatment
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
to get new dynamic 4D imaging by one rotational angiography during routine treatment
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
Cases considered that a new technology is effective
Key exclusion criteria
not applicable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Izumi |
Organization
Nagoya University, Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
466-8550
Address
65 Turumai-cho, Show ward, Nagoya-city
TEL
052-744-2353
my-yuzu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Izumi |
Organization
Nagoya University, Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
466-8550
Address
65 Turumai-cho, Show ward, Nagoya-city
TEL
052-744-2353
Homepage URL
my-yuzu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Siemens Healthcare 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
IRB Nagoya University, Graduate School of Medicine
Address
65 Turumai-cho, Show ward, Nagoya-city
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
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
名古屋大学医学部付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 25 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Paper work has been delayed.
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
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 24 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025407
| 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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| Registered date | File name |
