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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038303
Receipt No. 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

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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
Email 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
Email chiakimk@cronos.ocn.ne.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043658

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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