UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038303 |
|---|---|
| Receipt number | R000043658 |
| Scientific Title | Multi-center, single arm, prospective registry trial of pre-surgical embolization for brain arteriovenous malformation using PHIL (PH-112) |
| Date of disclosure of the study information | 2019/10/16 |
| Last modified on | 2019/10/16 07:30:49 |
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Basic information
Public title
Prospective registry trial of pre-surgical embolization for brain arteriovenous malformation using PHIL
Acronym
Prospective registry trial of pre-surgical embolization for brain AVM using PHIL
Scientific Title
Multi-center, single arm, prospective registry trial of pre-surgical embolization for brain arteriovenous malformation using PHIL (PH-112)
Scientific Title:Acronym
Prospective registry trial of pre-surgical embolization for brain AVM using PHIL (PH-112)
Region
| Japan |
Condition
Condition
brain arteriovenous malformation
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety and efficacy of pre-surgical embolization of brain arteriovenous malformation using PHIL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
50% or more volume reduction by embolization and no mortality within 30days after surgical resection
Key secondary outcomes
1. bleeding volume during surgical resection
2. duration of surgical resection
3. severe adverse event related to embolization
4. all mortality within 30days after embolization
5. all stroke within 30days after embolization
6. neurological deterioration within 30days after embolization
7. modified Rankin Scale 30days after embolization surgical resection
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
pre-surgical endovascular embolization using PHIL
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. brain arteriovenous malformation
2. indicated to surgical resection
3. 4 or less of modified Rankin Scale
4. 1 to 4 of Spetzler & Martin Grade
5. exist feeding artery candidate to trans-arterial embolization
6. obtain documented consent form
Key exclusion criteria
1. impossible to use heparin
2. history of severe alergic reaction to contrast media
3. impossible to navigate microcatheter to ideal position
4. intolelance to provocative test
5. no distal flow by vasospasm
6. liver dysfunction (AST 120U or larger) or renal dysfunction (CRTN 2.0mg/dL or larger)
7. history of embolization using non-adhesive liquid material for target brain AVM
8. candidate to another approving trial
9. pregnant or possible to pregnancy lady
10. inappropriate patient for this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center General Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL
078-302-4321
n.sakai@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center General Hospital
Division name
Center for Clinical Research and Innovation
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL
078-302-4321
Homepage URL
chiakimk@cronos.ocn.ne.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Terumo Co. Ltd.
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
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
Tel
078-302-4321
chiken@kcho.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
広南病院、筑波大学、埼玉医科大学国際医療センター、順天堂大学、昭和大学藤が丘病院、富山大学、名古屋大学、京都大学、大阪医療センター、兵庫医科大学、神戸市立医療センター中央市民病院、岡山大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 16 | 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
| 2019 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043658
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| Registered date | File name |
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