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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038325
Receipt No. R000043668
Scientific Title Multi-center, single arm, prospective registry trial of transs-arterial embolization for dural arteriovenous fistula using PHIL (PH-112)
Date of disclosure of the study information 2019/10/18
Last modified on 2019/10/18

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Basic information
Public title Prospective registry trial of trans-arterial embolization for dural arteriovenous fistula using PHIL
Acronym Prospective registry trial of trans-arterial embolization for dAVF using PHIL
Scientific Title Multi-center, single arm, prospective registry trial of transs-arterial embolization for dural arteriovenous fistula using PHIL (PH-112)
Scientific Title:Acronym Prospective registry trial of trans-arterial embolization for dAVF using PHIL (PH-112)
Region
Japan

Condition
Condition dural arteriovenous fistula
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm safety and efficacy of trans-arterial embolization of dural arteriovenous fistula using PHIL
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes curative occlusion at 180 days after embolization and no pprocedure related mortality, stroke and severe hemorrhagic event within 30days after surgical resection
Key secondary outcomes 1. recanalization at 180 days after embolization
2. re-treatment related to recanalization at 180 days after embolization
3. neurological symptoms related to recanalization at 180 days after embolization
4. any death at 180 days after embolization
5. any stroke at 180 days after embolization
6, neurological deterioration at 180 days after embolization
7. modified Rankin Scale at 180 days after embolization

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 trans-arterial 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. dural arteriovenous fistula
2. difficult to cure with trans-venous embolization
3. 4 or less of modified Rankin Scale
4. exist feeding artery candidate to trans-arteri al embolization
5. 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 idea l position
4. intolelance to provocative test
5. no distal flow by vasospasm
6. liver dysfunction (AST 120U or larger) or re nal dysfunction (CRTN 2.0mg/dL or larger)
7. history of embolization using non-adhesive li quid 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 22

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, 650-0047 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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 18 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 20 Day
Last follow-up date
2021 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
2019 Year 10 Month 18 Day
Last modified on
2019 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043668

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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