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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011617
Receipt No. R000013587
Scientific Title Safety and efficacy of coil embolization of body trunk vascular lesions using Hydrocoils: a multicenter study
Date of disclosure of the study information 2013/09/01
Last modified on 2016/09/04

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Basic information
Public title Safety and efficacy of coil embolization of body trunk vascular lesions using Hydrocoils: a multicenter study
Acronym Coil embolization of body trunk lesions with Hydrocoils: a multicenter study
Scientific Title Safety and efficacy of coil embolization of body trunk vascular lesions using Hydrocoils: a multicenter study
Scientific Title:Acronym Coil embolization of body trunk lesions with Hydrocoils: a multicenter study
Region
Japan

Condition
Condition Body trunk vascular lesions
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy of coil embolization for body trunk vascular lesion using Hydrocoils in comparison with embolization using bare platinum coils
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Effectiveness
i. Embolization effects immedatery after treatment
ii. Length of embolized vessel, number of used coils, total length of used coils

Safety
i. adverse event
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Hydrogel-coating coil grou
Interventions/Control_2 Non-hydrogel coating coil group (Bare platinum coil group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Body trunk vascular lesions which can be treated by coil embolization, including arteriovenous shunt, portosystemic shunt, parent artery occlusion for aneurysm, protective embolization of normal artery, etc.
2. Patients aged 20 or over at the time of informed consent
Key exclusion criteria 1. A case with active bleeding
2. A case with active infective disease
3. A case with active asthma and/or severe allergic disease
4. A case with congestive heart failure
5. A case with blood disease
6. A case with severe hepatic and/or renal disease
7. A case with uncontrollable malignant disease
8. Pregnant
9. A case whose performance status is over 3
10. WBC count is less than 2000 or granulocyte count is less than 1000
11. Platelet count is less than 50,000/mm3 or PT-INR is over 1.5
12. A case deemed to be inadequate for this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiro Kiyosue
Organization Oita University Faculty of Medicine
Division name Radiology
Zip code
Address Idaigaoka, 1-1, Hasama-machi, Yufu-shi, Oita
TEL 097-586-5934
Email hkiyosue@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Tanoue
Organization Oita University Faculty of Medicine
Division name Radiology
Zip code
Address Idaigaoka, 1-1, Hasama-machi, Yufu-shi, Oita
TEL 097-586-5934
Homepage URL
Email stanoue@oita-u.ac.jp

Sponsor
Institute Department of Radiology, Oita University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Radiology, Oita University Faculty of Medicine
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
Email

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 大分大学,慶応大学,大阪大学,奈良県立医科大学,久留米大学

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 01 Day
Last modified on
2016 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013587


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