UMIN-CTR Clinical Trial

Basic information
Public title	Clinical application of indocyanine green angiography
Acronym	Clinical application of indocyanine green angiography
Scientific Title	Clinical application of indocyanine green angiography
Scientific Title:Acronym	Clinical application of indocyanine green angiography
Region	Japan

Condition
Condition	Patients who will undergo blood flow reconstruction or vascularized tissue transfer will be included. Patients who are under 15 years old or allergic to any kind of medicine will be excluded.
Classification by specialty	Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to elucidate the efficacy of ICG angiography in vessel anastomosis or tissue transfer. This method does not need radiation and can show us the condition of vessel anastomosis site directly during the operations.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will administer ICG intravenously and check the condition of anastomosis site.
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	We will administer ICG intravenously during the operations, and check the condition of vessel anastomosis site or blood flow of the transferred tissue.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who will undergo blood flow reconstruction or vascularized tissue transfer.
Key exclusion criteria	Patients who are under 15 years old or allergic to any kind of medicine.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Isao Koshima
Organization	The University of Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL	03-3815-5411
Email	koushimai-pla@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsunaga Narushima
Organization	The University of Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL	03-3815-5411
Homepage URL
Email	sancho-ps@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	YES
Study ID_1	2891
Org. issuing International ID_1	The University of Tokyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 04 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	Preinitiation
Date of protocol fixation	2015 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 04 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	2015 Year 06 Month 02 Day
Last modified on	2016 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020596

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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