UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020435 |
|---|---|
| Receipt number | R000023604 |
| Scientific Title | Endovascular treatment using N-Butyl Cyanoacrylate (NBCA) liquid adhesive for arteriovenous malformations, dural arteriovenous fistulas and brain tumors |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2016/01/17 12:28:57 |
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Basic information
Public title
Endovascular treatment using N-Butyl Cyanoacrylate (NBCA) liquid adhesive for arteriovenous malformations, dural arteriovenous fistulas and brain tumors
Acronym
Endovascular treatment using NBCA for arteriovenous malformations, dural arteriovenous fistulas and brain tumors
Scientific Title
Endovascular treatment using N-Butyl Cyanoacrylate (NBCA) liquid adhesive for arteriovenous malformations, dural arteriovenous fistulas and brain tumors
Scientific Title:Acronym
Endovascular treatment using NBCA for arteriovenous malformations, dural arteriovenous fistulas and brain tumors
Region
| Japan |
Condition
Condition
arteriovenous malformations, dural arteriovenous fistulas and brain tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the influence of endovascular treatment using N-Butyl Cyanoacrylate (NBCA) liquid adhesive for arteriovenous malformations, dural arteriovenous fistulas and brain tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation for the endovascular treatment using NBCA for the feeding arteries
The treatment next day: MRI
Key secondary outcomes
Occurrence of the treatment complication and adverse event
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
| Medicine |
Interventions/Control_1
treatment using NBCA
The dosage period: during the endovascular treatment
The dosage:0.1ml-0.5ml NBCA per feeding artery
The dosage number of times: 1-5 feeding arteries
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
1. large size arteriovenous malformations could not operated simply or radiosurgery simply
2. dural arteriovenous malformations could not reached by transvenous approach
3. large brain tumors that have vascular feeders
Key exclusion criteria
the cases whose feeding arteries could not reached by micro catheters
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naked Mitsutoshi |
Organization
Graduate School of Medical Science Kanazawa university
Division name
Department of Neurosurgery
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2384
mnakada@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mohri Masanao |
Organization
Graduate School of Medical Science Kanazawa university
Division name
Department of Neurosurgery
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2384
Homepage URL
mmohri@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Uchiyama Naoyuki
Mohri Masanao
Misaki Kouichi
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
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
金沢大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023604
