UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018910 |
|---|---|
| Receipt number | R000021880 |
| Scientific Title | Evaluation of tissue blood supply with intraoperative indocyanine green fluorescence imaging |
| Date of disclosure of the study information | 2015/09/04 |
| Last modified on | 2019/09/07 09:28:09 |
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Basic information
Public title
Evaluation of tissue blood supply with intraoperative indocyanine green fluorescence imaging
Acronym
Evaluation of tissue blood supply with intraoperative indocyanine green fluorescence imaging
Scientific Title
Evaluation of tissue blood supply with intraoperative indocyanine green fluorescence imaging
Scientific Title:Acronym
Evaluation of tissue blood supply with intraoperative indocyanine green fluorescence imaging
Region
| Japan |
Condition
Condition
Cases of tissue transplantation with microsurgery
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of intraoperative indocyanine green fluorescence imaging in tissue transplantation surgery from the viewpoint of evaluating blood supply
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patency of anastomosed vessels and distribution of indocyanine green fluorescence in transplanted tissues
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
One to three times of intravenous administration of indocyanine green (0.1-0.3mg/kg) during surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of tissue transplantation with microsurgery
Key exclusion criteria
Patients under the age of 20, with indocyanine green or iodine allergy, and with pregnancy or lactation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tateki Kubo |
Organization
Osaka university graduate school of medicine
Division name
Department of plastic surgery
Zip code
Address
2-2-C11 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-6056
tateki@psurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tateki Kubo |
Organization
Osaka university graduate school of medicine
Division name
Department of plastic surgery
Zip code
Address
2-2-C11 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-6056
Homepage URL
tateki@psurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021880
