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UMIN-CTR Clinical Trial |
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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 |
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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |