UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011617 |
|---|---|
| Receipt number | 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 | 2021/03/08 12:55:19 |
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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
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
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 | Hiro |
| Middle name | |
| Last name | Kiyosue |
Organization
Oita University Faculty of Medicine
Division name
Radiology
Zip code
879-5593
Address
Idaigaoka, 1-1, Hasama-machi, Yufu-shi, Oita
TEL
097-586-5934
hkiyosue@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Tanoue |
Organization
Oita University Faculty of Medicine
Division name
Radiology
Zip code
879-5593
Address
Idaigaoka, 1-1, Hasama-machi, Yufu-shi, Oita
TEL
097-586-5934
Homepage URL
stanoue@oita-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Oita University Faculty of Medicine
Institute
Department
Personal name
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
General Clinical Research Center, Oita University Hospital
Address
1-1, Idaigaoka, Hasama-machi, Yufu, Oita
Tel
097-586-6163
gcrcjimu@oita-u.ac.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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
77
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 27 | Day |
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
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013587
