UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of the safety and efficacy of sclerotherapy in patients with venous malformation
Title of the study (Brief title)	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	Kazuo Kishi
Organization	School of Medicine, Keio University
Division name	Plastic and Reconstructive Surgery
Address	35 shinanomachi shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	kkishi@a7.keio.jp

Public contact
Name of contact person	Noriko Aramaki
Organization	School of Medicine, Keio University
Division name	Plastic and Reconstructive Surgery
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2013 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012036