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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002558
Receipt No. R000003127
Scientific Title Clinical trial of ethanolamine oleate sclerotherapy for hemangioma in the oral and maxillofacial region
Date of disclosure of the study information 2009/10/01
Last modified on 2018/01/18

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Basic information
Public title Clinical trial of ethanolamine oleate sclerotherapy for hemangioma in the oral and maxillofacial region
Acronym Clinical trial of ethanolamine oleate sclerotherapy for hemangioma
Scientific Title Clinical trial of ethanolamine oleate sclerotherapy for hemangioma in the oral and maxillofacial region
Scientific Title:Acronym Clinical trial of ethanolamine oleate sclerotherapy for hemangioma
Region
Japan

Condition
Condition low flow hemangioma of oral and maxillofacial region
Classification by specialty
Radiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of ethanolamine oleate sclerotherapy for low flow hemangioma in the oral and maxillofacial region
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of tumor size in clinical findings or MRI remarks.
Recurrence rate at 1 year after treatment
Key secondary outcomes Incidences of complications or side effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 We measure the blood flow in the tumor with CT using contrast medium.
If the tumor ia low flow, we inject 5% ethanolamine oleate and watch for 5 minutes. After that, we collect the sclerosing agent.
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 Patient who has low flow hemangioma
Patient who accept the participation in this trial
Key exclusion criteria Patient who has kidney trouble (24h CCr<= 70L/day)
Patient who is unsuitable to this trial
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Yamashita
Organization Saga University Hospital
Division name Oral and maxillofacial Surgery
Zip code
Address 5-1-1, Nabeshima, Saga, Japan
TEL 0952-34-2397
Email Yamashy2@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Danjo
Organization Saga University Hospital
Division name Oral and maxillofacial Surgery
Zip code
Address 5-1-1, Nabeshima, Saga, Japan
TEL 0952-34-2397
Homepage URL
Email danjoat@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Radiology, Saga University Hospital
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 佐賀大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2009 Year 10 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 Open public recruiting
Date of protocol fixation
2009 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 28 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003127

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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