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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025845
Receipt No. R000029720
Scientific Title The efficacy of local injection of indocyanine green for visualizing lymphatic malformation
Date of disclosure of the study information 2017/01/25
Last modified on 2018/03/05

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Basic information
Public title The efficacy of local injection of
indocyanine green for visualizing
lymphatic malformation
Acronym Visualization of lymphatic malformation
Scientific Title The efficacy of local injection of
indocyanine green for visualizing
lymphatic malformation
Scientific Title:Acronym Visualization of lymphatic malformation
Region
Japan

Condition
Condition lymphatic malformation
Classification by specialty
Surgery in general Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Visualization of lymphatic malformation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparing the area of lymphatic
malformation detected by indocyanine green injection with other image diagnosis
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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Local injection of indocyanine green
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
1 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria lymphatic malformation patients
Key exclusion criteria Having allergy to iodine
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yujiro Tanaka
Organization Nagoya University Graduate School of
Medicine
Division name Department of Pediatric Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Email tanakayujiro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yujiro Tanaka
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Homepage URL
Email shounigeka@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of
Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of
Medicine
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
2017 Year 01 Month 25 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 25 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029720

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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