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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007625
Receipt No. R000009004
Scientific Title Radiofrequency ablation for cavernous lymphangiomas of the tongue and the oral cavity.
Date of disclosure of the study information 2012/04/01
Last modified on 2016/10/03

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Basic information
Public title Radiofrequency ablation for cavernous lymphangiomas of the tongue and the oral cavity.
Acronym Radiofrequency ablation for cavernous lymphangiomas of the tongue and the oral cavity.
Scientific Title Radiofrequency ablation for cavernous lymphangiomas of the tongue and the oral cavity.
Scientific Title:Acronym Radiofrequency ablation for cavernous lymphangiomas of the tongue and the oral cavity.
Region
Japan

Condition
Condition Cavernous lymphangiomas of the tongue and the oral cavity
Classification by specialty
Surgery in general Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of radiofrequency ablation for cavernous lymphangioma of the tongue and the oral cavity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes subjective symptom
gross pathology
size of the tumor
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We perform radiofrequency ablation for cavernous lymphangioma of the tongue and the oral cavity.
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. Tumor located at pucturable site
2. Regardless of age or past treatment
3. Regardless of the other site of lymphangioma
4. Regardless of the component of hemangioma
5. Written informed consent
Key exclusion criteria 1. With Complications which have serious effect on the ablation
2. Tumor located at unpuncturable site
3. Tumor located near the important nerves or vessels
4. Inappropriate patient for this study judged by the investigators
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuo Noda
Organization Okayama university hospital
Division name Department of Pediatric Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city,Japan
TEL +81-86-223-7151
Email ntakups@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Oyama
Organization Okayama university hospital
Division name Department of Pediatric Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city,Japan
TEL +81-86-223-7151
Homepage URL
Email oyama@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization None
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 岡山大学病院

Other administrative information
Date of disclosure of the study information
2012 Year 04 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
Results
Tumor did not significantly reduced by RFA. But symptoms such as pain and bleeding were improved due to disappearance of tumor exposure to mucosal surface.
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
2012 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 04 Month 20 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 30 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009004

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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