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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018910
Receipt No. 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

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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
Email 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
Email tateki@psurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka university 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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