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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000010320
Receipt No. 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

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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
Email 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
Email nonken@2001.jukuin.keio.ac.jp

Sponsor
Institute Plastic and Reconstructive Surgery, School of Medicine, Keio University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012036

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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