UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical application of indocyanine green angiography
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Isao Koshima
Organization	The University of Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
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	Mitsunaga Narushima
Organization	The University of Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 06 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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