UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017782 |
|---|---|
| Receipt number | 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 09:08:10 |
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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
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
sancho-ps@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020596
