UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017782
Receipt No. R000020596
Scientific Title Clinical application of indocyanine green angiography
Date of disclosure of the study information 2015/06/04
Last modified on 2016/07/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.