UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010320 |
|---|---|
| Receipt number | R000012036 |
| Scientific Title | A clinical study of the safety and efficacy of sclerotherapy in patients with venous malformation |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2017/03/30 10:29:15 |
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Basic information
Public title
A clinical study of the safety and efficacy of sclerotherapy in patients with venous malformation
Acronym
Safety and efficacy of sclerotherapy for venous malformation
Scientific Title
A clinical study of the safety and efficacy of sclerotherapy in patients with venous malformation
Scientific Title:Acronym
Safety and efficacy of sclerotherapy for venous malformation
Region
| Japan |
Condition
Condition
venous malformation
Classification by specialty
| Orthopedics | Radiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of foam sclerotherapy for venous malformation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Efficacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Foam sclerotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients who have symptomatic venus malformation
2) Those with the informed consent obtained by the patient him-/herself or his/her parent.
Key exclusion criteria
Those who are allergic to iodinated contrast material or polidocanol.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kishi |
Organization
School of Medicine, Keio University
Division name
Plastic and Reconstructive Surgery
Zip code
Address
35 shinanomachi shinjuku-ku, Tokyo
TEL
03-3353-1211
kkishi@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Aramaki |
Organization
School of Medicine, Keio University
Division name
Plastic and Reconstructive Surgery
Zip code
Address
35 shinanomachi shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nonken@2001.jukuin.keio.ac.jp
Sponsor or person
Institute
Plastic and Reconstructive Surgery, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio University
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
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
| 2013 | Year | 04 | 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
Date of protocol fixation
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 26 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012036
